OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS by IMPLANT INNOVATIONS, INC.

BIOMET 3i dental 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 or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

BIOMET 3i Osseotite and NanoTite 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.

Device Description

BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface, both with and without the additional proprietary NanoTite treatment. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Implants are also offered in various diameters and length.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental implant. 510(k)s generally demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria with detailed studies like those of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training data is not applicable to this type of submission.

Instead, the submission focuses on demonstrating that the BIOMET 3i Dental Implants have technological characteristics and intended uses that are substantially equivalent to already legally marketed predicate devices. The "Performance Testing" section mentions:

Laboratory testing: Conducted to determine device functionality and conformance to design input requirements and FDA's Class II special controls guidance document.
Risk analysis: Conducted in accordance with ISO 14971.
Results: Included in the premarket notification submissions for the predicate device.

The FDA's decision letter also confirms that they have determined the device is "substantially equivalent" to legally marketed predicate devices.

Summary

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K062636

Image /page/0/Picture/1 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a stylized font. The '3i' portion of the logo is smaller than the 'BIOMET' portion.

JUN - 1 2007

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Submitter	BIOMET 3i, Inc.4555 RiversidePalm Beach Gardens, FL 33410	Device Description	BIOMET 3i Dental Implants are provided with theproprietary OSSEOTITE acid-etched surface, both withand without the additional proprietary NanoTitetreatment. Implants are offered in both tapered andparallel-walled/straight designs, and each design providesofferings for either external hex or internal connections.Implants are also offered in various diameters and length.
Contact	Jacquelyn A. Hughes, RACDirector, RA/QABIOMET 3i, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6819Fax. 561-514-6316Email jhughes@3implant.com	Indications for Use	BIOMET 3i dental implants are intended for surgicalplacement in the upper or lower jaw to provide a meansfor prosthetic attachment in single tooth restorations andin partially or fully edentulous spans with multiple singleteeth utilizing delayed or immediate loading, or as aterminal or intermediary abutment for fixed or removablebridgework, and to retain overdentures.
Date Prepared	May 30, 2007		BIOMET 3i Osseotite and NanoTite dental implants areintended for immediate function on single tooth and/ormultiple tooth applications when good primary stabilityis achieved, with appropriate occlusal loading, in order torestore chewing function.
Device Name	BIOMET 3i Dental Implants	TechnologicalCharacteristics	The design features and functions are identical to thecurrently available OSSEOTITE, OSSEOTITE NT,OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail,NanoTite and BIOMET 3i implants and cover screws.
Classification Name	Endosseous Dental Implants	Performance	Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act
DeviceClassification	Class IIDental Devices Panel21 CFR § 872.3640	Performance Testing	Laboratory testing was conducted to determine devicefunctionality and conformance to design inputrequirements, as well as FDA'S Class II special controlsguidance document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments. Riskanalysis was conducted in accordance with ISO 14971.Results from all of these tests were included in thepremarket notification submissions for the predicatedevice.
PredicateDevices	OSSEOTITE NT Dental Implants - K0142353i Innovation Implants and Cover Screws - K972444Threaded/Self-Tapping Threaded Implants - K935544OSSEOTITE Dental implants - K980549OSSEOTITE Dental Implants - K9833473i Dental Implants - K022009HA- Coated Endosseous Dental Implants - K9554283i OSSEOTITE NT Certain Implants - K0314753i IOL Implants - K0316323i Implants - K030614OSSEOTITE NT Certain Implants - K041402Prevail Implants – K0511893i OSSEOTITE Dental Implants - K051461NanoTite Dental Implants - K062432	Conclusion	BIOMET 3i Dental Implants are substantially equivalentto the dental implants described in the premarketnotification submissions for the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2007

Ms. Jacquelyn A. Hughes, RAC Director, Regulatory Affairs/Quality Assurance BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K062636

Trade/Device Name: BIOMET 3i Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 3, 2007 Received: May 4, 2007

Dear Ms. Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hughes

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sophie Y. M. ichleee DmD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a bold, sans-serif font. The "3i" portion of the logo is smaller than the "BIOMET" portion and is located to the right of it. The logo has a textured appearance.

Indications for Use Statement

510(k) Number (if known): K062636

Device Name: BIOMET 3i Dental Implants

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K062636
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Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.