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BIOMET 3i Dental Implants Important Product Information

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ZIMMER BIOMET Dental Systems

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EN IMPORTANT PRODUCT INFORMATION  This document applies to BIOMET 3i Dental Implants... nstructions for Use: For a detailed explanation of the osteotomy preparation and implant placement guidelines, please refer to the appropriate Surgical Manual(s)... escription: BIOMET 3i Dental Implants are manufactured from biocompatible titanium or titanium alloy... IOMET 3i Dental Implants include various surface treatments... or specific product descriptions, please refer to individual product labels... ndications for Use: BIOMET 3i Dental Implants, including the BIOMET 3i T3®, NanoTite™, OSSEOTITE® and 3i T3® Short Implants, are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures... he BIOMET 3i T3®, NanoTite™ and OSSEOTITE® Dental Implants may also utilize immediate loading for these indications... IOMET 3i T3®, NanoTite™ and OSSEOTITE® Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function... ontraindications: Placement of dental implants may be precluded by both patient conditions that are contraindications for surgery as well as hypersensitivity to commercially pure titanium or titanium alloy (including vanadium, aluminum, and calcium phosphate)... IOMET 3i Dental Implants should not be placed in patients where the remaining jaw bone is too diminished to provide adequate implant stability... arnings: Excessive bone loss or breakage of a dental implant may occur when an implant is loaded beyond its functional capability... hysiological and anatomical conditions may affect the performance of dental implants... ishandling of small components inside the patient’s mouth carries a risk of ingestion, aspiration and/or swallowing... orcing the implant into the osteotomy deeper than the depth established by the drills can result in damage to the implant, driver, or osteotomy... or short implants, clinicians should closely monitor patients for any of the following conditions: peri-implant bone loss, changes to the implant’s response to percussion or radiographic changes in bone-to-implant contact along the implant’s length... f the implant shows mobility or greater than 50% bone loss, the implant should be evaluated for possible removal... f a clinician chooses a short implant, then the clinician should consider a two-stage surgical approach, splinting a short implant to an additional implant, and placement of the widest possible fixture... n addition, the clinician should allow longer periods for osseointegration and avoid immediate loading... euse of BIOMET 3i products that are labeled for single-use may result in product contamination, patient infection and/or failure of the device to perform as intended... RI Safety Information: Non-clinical testing has demonstrated the BIOMET 3i Dental Implants are MR Conditional...  patient with this device can be safely scanned in an MR system meeting the following conditions: •	Static magnetic field of 1... T and 3... T • Maximum spatial field gradient of 3,000 gauss/cm (30 T/m) •	Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode) Under the scan conditions defined above, the BIOMET 3i Dental Implants are expected to produce a maximum temperature rise of less than 4ºC at 3... T and 3ºC at 1... T after 15 minutes of continuous scanning... n non-clinical testing, the image artifact caused by the device extends radially up to 2... cm and 2... cm from the implant when imaged with a gradient echo-pulse sequence and 3... T and 1... T MRI systems, respectively... recautions: These devices are only to be used by trained professionals... he surgical and restorative techniques required to properly utilize these devices are highly specialized and complex procedures... mproper technique can lead to implant failure, loss of supporting bone, restoration fracture, screw loosening ingestion, aspiration and/or swallowing... hen the clinician has determined adequate primary stability is achieved, immediate functional loading can be considered... he following should be taken into consideration when placing dental implants: bone quality, oral hygiene, and medical conditions such as blood disorders or uncontrolled hormonal conditions... he healing period varies depending on the quality of the bone at the implantation site, the tissue response to the implanted device and the surgeon’s evaluation of the patient’s bone density at the time of the surgical procedure... roper occlusion should be evaluated on the implant restoration to avoid excessive force during the healing period on the implant... t is recommended that implants less than 4 mm diameter NOT be placed in the posterior regions... terility: All dental implants are supplied sterile and are labeled “STERILE”... ll products sold sterile are for single-use before the expiration date printed on the product label... o not use sterile products if the packaging has been damaged or previously opened... o not re-sterilize... torage and Handling: Devices should be stored at room temperature... efer to individual product labels and the Surgical Manual for special storage or handling conditions... Potential Adverse Events: Potential adverse events associated with the use of dental implants may include: failure to integrate, loss of integration, dehiscence requiring bone grafting, perforation of the maxillary sinus, inferior border, lingual plate, labial plate, inferior alveolar canal, or gingiva, infection as reported by abscess, fistula, suppuration, inflammation, or radiolucency, persistent pain, numbness, paresthesia, hyperplasia, excessive bone loss requiring intervention, implant breakage or fracture, systemic infection, nerve injury, ingestion, aspiration and/or swallowing... aution: U...  Federal Law restricts this device to sale by or on the order of a licensed dentist or physician... Date of Manufacture  Batch code  Catalogue number  Caution, consult accompanying documents  Do not re-sterilize  Do not re-use  Consult Instructions for Use www... u... omet3i... m  Sterilized using gamma irradiation  Use by date  Do not use if package is damaged  By prescription only  Authorized European Representative  Legal Manufacturer  MR Conditional  BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410, USA 1-800-342-5454 Outside The U... : +1-561-776-6700 Fax: +1-561-776-1272 www... omet3i... m BIOMET 3i Dental Iberica, S...  WTC Almeda Park, Ed... , Planta 2 C/Tirso de Molina, 40 08940 – Cornellà de Llobregat (Barcelona) Spain Phone: +34 934 705 500 Fax: +34 933 717 849  P-IIS086GI Rev...  11/2015
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biomet_3i_dental_implants_important_product_informa.pdf

Page 1

EN IMPORTANT PRODUCT INFORMATION

This document applies to BIOMET 3i Dental Implants.

Instructions for Use: For a detailed explanation of the osteotomy preparation and implant placement

guidelines, please refer to the appropriate Surgical Manual(s).

Description: BIOMET 3i Dental Implants are manufactured from biocompatible titanium or titanium

alloy. BIOMET 3i Dental Implants include various surface treatments. For specific product descriptions,

please refer to individual product labels.

Indications for Use: BIOMET 3i Dental Implants, including the BIOMET 3i T3®, NanoTite™, OSSEOTITE®

and 3i T3® Short Implants, are intended for surgical placement in the upper or lower jaw to provide

a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans

with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment

for fixed or removable bridgework, and to retain overdentures.

The BIOMET 3i T3®, NanoTite™ and OSSEOTITE® Dental Implants may also utilize immediate loading

for these indications. BIOMET 3i T3®, NanoTite™ and OSSEOTITE® Dental Implants are intended for

immediate function on single tooth and/or multiple tooth applications when good primary stability

is achieved, with appropriate occlusal loading, in order to restore chewing function.

Contraindications: Placement of dental implants may be precluded by both patient conditions that

are contraindications for surgery as well as hypersensitivity to commercially pure titanium or titanium

alloy (including vanadium, aluminum, and calcium phosphate).

BIOMET 3i Dental Implants should not be placed in patients where the remaining jaw bone is too

diminished to provide adequate implant stability.

Warnings: Excessive bone loss or breakage of a dental implant may occur when an implant is loaded

beyond its functional capability. Physiological and anatomical conditions may affect the performance

of dental implants.

Mishandling of small components inside the patient’s mouth carries a risk of ingestion, aspiration

and/or swallowing.

Forcing the implant into the osteotomy deeper than the depth established by the drills can result

in damage to the implant, driver, or osteotomy.

For short implants, clinicians should closely monitor patients for any of the following conditions:

peri-implant bone loss, changes to the implant’s response to percussion or radiographic changes

in bone-to-implant contact along the implant’s length. If the implant shows mobility or greater than

50% bone loss, the implant should be evaluated for possible removal. If a clinician chooses a short

implant, then the clinician should consider a two-stage surgical approach, splinting a short implant

to an additional implant, and placement of the widest possible fixture. In addition, the clinician

should allow longer periods for osseointegration and avoid immediate loading.

Reuse of BIOMET 3i products that are labeled for single-use may result in product contamination,

patient infection and/or failure of the device to perform as intended.

MRI Safety Information:

Non-clinical testing has demonstrated the BIOMET 3i Dental Implants are MR Conditional. A patient

with this device can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 T and 3.0 T

• Maximum spatial field gradient of 3,000 gauss/cm (30 T/m)

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg

(Normal Operating Mode)

Under the scan conditions defined above, the BIOMET 3i Dental Implants are expected to produce

a maximum temperature rise of less than 4ºC at 3.0 T and 3ºC at 1.5 T after 15 minutes of continuous

scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 2.7 cm and 2.2 cm

from the implant when imaged with a gradient echo-pulse sequence and 3.0 T and 1.5 T MRI systems,

respectively.

Precautions: These devices are only to be used by trained professionals. The surgical and restorative

techniques required to properly utilize these devices are highly specialized and complex procedures.

Improper technique can lead to implant failure, loss of supporting bone, restoration fracture, screw

loosening ingestion, aspiration and/or swallowing. When the clinician has determined adequate

primary stability is achieved, immediate functional loading can be considered.

The following should be taken into consideration when placing dental implants: bone quality,

oral hygiene, and medical conditions such as blood disorders or uncontrolled hormonal conditions.

The healing period varies depending on the quality of the bone at the implantation site, the tissue

response to the implanted device and the surgeon’s evaluation of the patient’s bone density at the

time of the surgical procedure. Proper occlusion should be evaluated on the implant restoration to

avoid excessive force during the healing period on the implant.

It is recommended that implants less than 4 mm diameter NOT be placed in the posterior regions.

Sterility: All dental implants are supplied sterile and are labeled “STERILE”. All products sold sterile

are for single-use before the expiration date printed on the product label. Do not use sterile products

if the packaging has been damaged or previously opened. Do not re-sterilize.

Storage and Handling: Devices should be stored at room temperature. Refer to individual product

labels and the Surgical Manual for special storage or handling conditions.

Potential Adverse Events: Potential adverse events associated with the use of dental implants

may include: failure to integrate, loss of integration, dehiscence requiring bone grafting, perforation

of the maxillary sinus, inferior border, lingual plate, labial plate, inferior alveolar canal, or gingiva,

infection as reported by abscess, fistula, suppuration, inflammation, or radiolucency, persistent pain,

numbness, paresthesia, hyperplasia, excessive bone loss requiring intervention, implant breakage

or fracture, systemic infection, nerve injury, ingestion, aspiration and/or swallowing.

Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed dentist or physician.

Date of Manufacture

Batch code

Catalogue number

Caution, consult accompanying

documents

Do not re-sterilize

Do not re-use

Consult Instructions for Use

www.ifu.biomet3i.com

Sterilized using gamma irradiation

Use by date

Do not use if package is damaged

By prescription only

Authorized European Representative

Legal Manufacturer

MR Conditional

BIOMET 3i

4555 Riverside Drive

Palm Beach Gardens, FL 33410, USA

1-800-342-5454

Outside The U.S.: +1-561-776-6700

Fax: +1-561-776-1272

www.biomet3i.com

BIOMET 3i Dental Iberica, S.L.

WTC Almeda Park, Ed. 4, Planta 2

C/Tirso de Molina, 40

08940 – Cornellà de Llobregat

(Barcelona) Spain

Phone: +34 934 705 500

Fax: +34 933 717 849

P-IIS086GI Rev. F 11/2015

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