← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K062636 # OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS (K062636) _Implant Innovations, Inc. · DZE · Jun 1, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K062636 ## Device Facts - **Applicant:** Implant Innovations, Inc. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Jun 1, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use 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 Story BIOMET 3i Dental Implants are endosseous implants designed for surgical placement in the jaw to support prosthetic restorations. Implants feature proprietary OSSEOTITE acid-etched surfaces, with or without NanoTite treatment; available in tapered or parallel-walled designs with external hex or internal connections. Used by dental surgeons in clinical settings to restore chewing function for patients with missing teeth. The device acts as an anchor for single tooth restorations, bridgework, or overdentures. Clinical benefit includes restoration of oral function and aesthetics. Operation involves surgical implantation into the jawbone; success relies on achieving primary stability for immediate or delayed loading protocols. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by bench testing conducted to determine device functionality and conformance to design input requirements, as well as adherence to the FDA Class II special controls guidance document for Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was performed per ISO 14971. ## Technological Characteristics Endosseous dental implants with OSSEOTITE acid-etched surface and optional NanoTite treatment. Designs include tapered and parallel-walled/straight configurations with external hex or internal connections. Various diameters and lengths available. Device is a mechanical implant; no software or energy source. Sterilization and material specifications are consistent with previously cleared predicate devices. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - OSSEOTITE NT Dental Implants ([K014235](/device/K014235.md)) - 3i Innovation Implants and Cover Screws ([K972444](/device/K972444.md)) - Threaded/Self-Tapping Threaded Implants ([K935544](/device/K935544.md)) - OSSEOTITE Dental implants ([K980549](/device/K980549.md)) - OSSEOTITE Dental Implants ([K983347](/device/K983347.md)) - 3i Dental Implants ([K022009](/device/K022009.md)) - HA- Coated Endosseous Dental Implants ([K955428](/device/K955428.md)) - 3i OSSEOTITE NT Certain Implants ([K031475](/device/K031475.md)) - 3i IOL Implants ([K031632](/device/K031632.md)) - 3i Implants ([K030614](/device/K030614.md)) - OSSEOTITE NT Certain Implants ([K041402](/device/K041402.md)) - Prevail Implants ([K051189](/device/K051189.md)) - 3i OSSEOTITE Dental Implants ([K051461](/device/K051461.md)) - NanoTite Dental Implants ([K062432](/device/K062432.md)) ## Related Devices - [K063341](/device/K063341.md) — 3I OSSEOTITE CERTAIN DENTAL IMPLANTS · Implant Innovations, Inc. · Apr 30, 2007 - [K062432](/device/K062432.md) — NANOTITE DENTAL IMPLANTS · Implant Innovations, Inc. · Feb 22, 2007 - [K072363](/device/K072363.md) — NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX · Biomet 3i, Inc. · Jan 31, 2008 - [K133049](/device/K133049.md) — 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS · Biomet 3i · Jan 8, 2014 - [K063286](/device/K063286.md) — OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE · Implant Innovations, Inc. · Apr 24, 2007 ## Submission Summary (Full Text) {0}------------------------------------------------ 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.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 | Device Description | BIOMET 3i Dental Implants are provided with the<br>proprietary OSSEOTITE acid-etched surface, both with<br>and without the additional proprietary NanoTite<br>treatment. Implants are offered in both tapered and<br>parallel-walled/straight designs, and each design provides<br>offerings for either external hex or internal connections.<br>Implants are also offered in various diameters and length. | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Jacquelyn A. Hughes, RAC<br>Director, RA/QA<br>BIOMET 3i, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. 561-776-6819<br>Fax. 561-514-6316<br>Email jhughes@3implant.com | Indications for Use | BIOMET 3i dental implants are intended for surgical<br>placement in the upper or lower jaw to provide a means<br>for prosthetic attachment in single tooth restorations and<br>in partially or fully edentulous spans with multiple single<br>teeth utilizing delayed or immediate loading, or as a<br>terminal or intermediary abutment for fixed or removable<br>bridgework, and to retain overdentures. | | Date Prepared | May 30, 2007 | | BIOMET 3i Osseotite and NanoTite dental implants are<br>intended for immediate function on single tooth and/or<br>multiple tooth applications when good primary stability<br>is achieved, with appropriate occlusal loading, in order to<br>restore chewing function. | | Device Name | BIOMET 3i Dental Implants | Technological<br>Characteristics | The design features and functions are identical to the<br>currently available OSSEOTITE, OSSEOTITE NT,<br>OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail,<br>NanoTite and BIOMET 3i implants and cover screws. | | Classification Name | Endosseous Dental Implants | Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act | | Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3640 | Performance Testing | Laboratory testing was conducted to determine device<br>functionality and conformance to design input<br>requirements, as well as FDA'S Class II special controls<br>guidance document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments. Risk<br>analysis was conducted in accordance with ISO 14971.<br>Results from all of these tests were included in the<br>premarket notification submissions for the predicate<br>device. | | Predicate<br>Devices | OSSEOTITE NT Dental Implants - K014235<br>3i Innovation Implants and Cover Screws - K972444<br>Threaded/Self-Tapping Threaded Implants - K935544<br>OSSEOTITE Dental implants - K980549<br>OSSEOTITE Dental Implants - K983347<br>3i Dental Implants - K022009<br>HA- Coated Endosseous Dental Implants - K955428<br>3i OSSEOTITE NT Certain Implants - K031475<br>3i IOL Implants - K031632<br>3i Implants - K030614<br>OSSEOTITE NT Certain Implants - K041402<br>Prevail Implants – K051189<br>3i OSSEOTITE Dental Implants - K051461<br>NanoTite Dental Implants - K062432 | Conclusion | BIOMET 3i Dental Implants are substantially equivalent<br>to the dental implants described in the premarket<br>notification submissions for the predicate devices. | {1}------------------------------------------------ . . : : {2}------------------------------------------------ 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ 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: 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. 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)  Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number: | K062636 | |----------------|---------| |----------------|---------| --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K062636](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K062636) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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