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
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
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,
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
Caution, consult accompanying
Do not re-sterilize
Do not re-use
Consult Instructions for Use
Sterilized using gamma irradiation
Use by date
Do not use if package is damaged
By prescription only
Authorized European Representative
4555 Riverside Drive
Palm Beach Gardens, FL 33410, USA
Outside The U.S.: +1-561-776-6700
BIOMET 3i Dental Iberica, S.L.
WTC Almeda Park, Ed. 4, Planta 2
C/Tirso de Molina, 40
08940 – Cornellà de Llobregat
Phone: +34 934 705 500
Fax: +34 933 717 849
P-IIS086GI Rev. F 11/2015