(200 days)
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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE® 2 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.
OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.
The provided document is a 510(k) summary for the OSSEOTITE® 2 Dental Implants. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device. Therefore, the "study" described is primarily focused on demonstrating substantial equivalence to predicate devices through bench testing and referencing existing clinical data rather than conducting a de novo clinical trial for the new device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on demonstrating that the OSSEOTITE® 2 Dental Implants are substantially equivalent to legally marketed predicate devices (OSSEOTITE II MODEL XIFOSSXXX (K100724) and OSSEOTITE; OSSEOTITE NT; XP; TG Implant(s) (K063286)). This means they must share the same intended use, indications for use, technological characteristics, and principles of operation, and any differences must not raise new questions of safety or effectiveness.
The document directly compares the proposed device to its predicates across various characteristics. The "reported device performance" in this context refers to showing that these characteristics are either identical or that any modifications (specifically the abutment connection) do not negatively impact performance as demonstrated by bench testing.
| Acceptance Criteria Category | Specific Criteria/Characteristic | OSSEOTITE® 2 Dental Implants Performance |
|---|---|---|
| Intended Use | Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. | Same as predicate devices. |
| Indications for Use | Intended for 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. Also: Provide immediate function when good primary stability is achieved with appropriate occlusal loading to restore chewing function. | Same as predicate devices. |
| Technological | * Implant Lengths: Specific ranges for different diameters. | Similar to predicate devices, with some overlap and minor variations in exact length options. Identified as "similar" in the text. |
| Characteristics | * Implant Body Diameters: Specific ranges. | Similar to predicate devices. |
| * Seating Platform Diameter: Specific measurements for different diameters. | Similar to predicate devices. | |
| * Material: Commercially Pure Titanium. | Same as predicate devices. | |
| * Biocompatibility: Yes. | Same as predicate devices. | |
| * Thread Design: 60° thread & 0.6mm pitch (Straight-Wall); 35° thread & 0.8mm pitch (Straight-Wall). | Similar; has both 60° (0.6mm) and 35° (0.8mm) options, comparable to predicates having either one or both with potentially slight differences in pitch. Identified as "similar" to one predicate for 60/0.6 and similar to another for 35/0.8. | |
| * Implant Design: Straight-walled implant body. | Same as predicate devices. | |
| * Self Tapping Feature: Integrated cutting flutes with apical taper. | Same as predicate devices. | |
| * Implant Surface: Full OSSEOTITE®. | Same as predicate devices. | |
| * Color-Coding: Anodized Seating Surface, Color-Coded Labeling. | Same as predicate devices. | |
| * Packaging: Packaged in sterile tray with cover screw. | Same as predicate devices. | |
| * Sterilization: Sterile (Gamma Irradiation). | Same as predicate devices. | |
| Shelf Life: 5 Years. | Same as predicate devices. | |
| * Implant Placement Protocol: Per BIOMET 3i Surgical Catalog. | Similar to predicate devices (CATM2 vs CATSM), implying a minor update to the catalog but similar approach. | |
| * Implant/Abutment Mating Connection: External Hexagon Connection (this is the key change from one predicate). | External Hexagon Connection, which is different from one predicate (Internal Hexagon) but similar to the other predicate. This is explicitly stated as the only major technological difference that is being cleared. | |
| * Mating Components: All BIOMET 3i External Hex Restorative Components. | Same as the External Hex predicate. | |
| Mechanical Performance | Device meets mechanical properties recommendations by FDA and ISO Standards, specifically ISO 14801:2007 "Dentistry – Dynamic Fatigue Test for Endosseous Dental Implants" (acceptance criteria not explicitly detailed but implied as "met the acceptance criteria"). | Met acceptance criteria for ISO 14801:2007. Evaluated worst-case scenario (30° pre-angled abutments) and compared to predicate designs. Performance testing indicates changes are safe and effective. |
| Clinical Performance | Successful integration and function of implants (based on "success of the implants at a defined follow-up time point post loading"). Assessment of insertion torque forces and implant failures. | Two clinical reports supporting the device (OSSEOTITE® 2) describe insertion torque forces, success rates, and analysis of failures and baseline torque values. These reports are cited as evidence. While specific success rates are not explicitly provided in the summary table, the inclusion of these reports supports clinical performance assessment relative to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the bench testing, the document states "All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs." It does not specify the numerical sample size for the fatigue testing according to ISO 14801:2007. For the clinical reports cited, specific sample sizes are also not provided in this summary document.
- Data Provenance:
- Bench Testing: The geographical origin is not specified, but it was conducted by "BIOMET 3i" implying internal company testing or contracted to a lab.
- Clinical Data: The summary mentions two clinical reports ("Insertional Torque Force, Osseotite 2 Placement Data, Pressure Necrosis" dated September 21st, 2011, and "BIOMET 3i Insertion Torque Report" dated November 10, 2011). These reports summarize clinical projects and "implant placement experience data". The summary doesn't explicitly state if they are retrospective or prospective, nor does it specify the country of origin. However, given they are reports on existing data, they are likely retrospective analyses of clinical experience.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the bench testing (ISO 14801:2007), ground truth is established by the standard itself and objective mechanical measurements. No human experts are involved in establishing ground truth in terms of diagnostic assessment.
- For the clinical reports, the "ground truth" relates to clinical outcomes (insertion torque, success, failure). These would have been established by the dental practitioners involved in the implant placement and follow-up. The document does not specify the number or qualifications of these experts; it only cites the reports.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- There is no mention of an adjudication method for either the bench testing or the clinical data in this 510(k) summary. Bench testing results are objective measurements against a standard. Clinical outcomes would typically be derived from patient records and the assessment of the treating clinicians, not through a separate adjudication panel described in this summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or is relevant for this submission. This device is a dental implant, a physical product, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" is defined by the acceptance criteria of the ISO 14801:2007 standard and the objective mechanical properties measured.
- For the clinical data cited, the ground truth is derived from clinical outcomes data (e.g., measured insertion torque values, implant success/failure at follow-up).
8. The sample size for the training set
- This is a special 510(k) for a physical medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing rely on established engineering principles and prior predicate devices.
9. How the ground truth for the training set was established
- As the concept of a "training set" for an AI algorithm is not applicable here, there is no ground truth established for a training set. The device's safety and effectiveness are established through comparison to predicates and bench testing against industry standards.
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NOV 1 8 2011
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 3i4555 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|
| Establishment Reg. Number: | 1038806 |
| Contact: | Martha I GaraySenior Regulatory Affairs SpecialistBIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-514 6316Email martha.garay@BIOMET.com |
| Date Prepared: | November 18th, 2011 |
| Trade/Proprietary Name: | OSSEOTITE® 2 Dental Implants |
| Common/Usual Name: | Root-Form Endosseous Dental Implant |
| Classification Name/ FDA Reviewing Branch: | Endosseous Dental Implant / Dental Panel |
| Device Classification/Code: | Class II - 21 CFR §872.3640 / DZE |
| Predicate Device Manufacturer: | K100724 - OSSEOTITE II MODEL XIFOSSXXX / BIOMET 3iK063286 – OSSEOTITE Dental Implants / BIOMET 3i |
| Purpose of the SPECIAL 510(k) notice: | The reason for this Special 510k submission is to request clearance formodification to a device that has been cleared under the 510(k) processreferred to herein as OSSEOTITE® 2 Dental Implants. Root-FormEndosseous Dental Implants are referenced under 21 CFR §872.3640and are considered Class II devices. |
| Device Description: | OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3iOSSEOTITE Implants, currently being sold worldwide. OSSEOTITE2® Dental Implants are provided with the proprietary OSSEOTITE dualacid-etched surface which has been in commercial distribution sincemarket clearance in 1995 and are made of Commercially Pure Titanium. |
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Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.
BIOMET 3i Dental Implants are intended for surgical placement in the Indications for Use: 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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE®2 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.
The predicates and OSSEOTITE® 2 Dental Implants have a number of very similar and equivalent design / technological characteristics, as follows:
| Criteria | PredicateOSSEOTITE IIMODELXIFOSSXXX(Internal Hex)K100724 | PredicateOSSEOTITE;OSSEOTITE NT;XP; TG Implant(s)(External Hex)K063286 | ProposedOSSEOTITE® 2Dental Implant(s)(External Hex)K111216 |
|---|---|---|---|
| Implant Lengths | Ø3.25: 8.5, 10.0,11.5, 13.0, 15.0,18.0mmØ4.0: 8.5, 10.0,11.5, 13.0, 15.0,18.0, 20.0mmØ5.0: 8.5, 10.0,11.5, 13.0, 15.0mmØ6.0: 8.5, 10.0,11.5, 13.0, 15.0mm | Ø3.25: 7(actual:6.6mm), 8.5,10, 11.5, 13, 15mmØ3.75: 7(actual:6.6mm),, 8.5,10, 11.5, 13, 15mmØ4: 7(actual:6.6mm),, 8.5,10, 11.5, 13, 15mmØ5: 7(actual:6.6mm),, 8.5,10, 11.5, 13, 15mmØ6: 7(actual:6.6mm),, 8.5,10, 11.5, 13, 15mm | Ø3.25: 6.5, 8.5, 10,11.5, 13, 15mmØ3.75: 6.5, 8.5, 10,11.5, 13, 15mmØ4: 6.5, 8.5, 10,11.5, 13, 15mmØ5: 6.5, 8.5, 10,11.5, 13, 15mmØ6: 6.5, 8.5, 10,11.5, 13, 15mm |
| Implant BodyDiameters | Ø3.25, 4.0, 5.0,6.0mm | Ø3.25, 3.75, 4, 5,6mm | Ø3.25, 3.75, 4, 5,6mm |
| Seating PlatformDiameter | Ø3.25: 3.4mmØ4: 4.1mmØ5: 5.0mmØ6: 6.0mm | Ø3.25: 3.4mmØ3.75: 4.1mmØ4: 4.1mmØ5: 5.0mmØ6: 6.0mm | Ø3.25: 3.4mmØ3.75: 4.1mmØ4: 4.1mmØ5: 5.0mmØ6: 6.0mm |
| Material | Commercially PureTitanium | Commercially PureTitanium | Commercially PureTitanium |
Technological Characteristics :
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111216
| Biocompatible | Yes | Yes | Yes |
|---|---|---|---|
| Thread Design | • 60° thread &0.6mm pitch(Straight-Wall)• 35° thread &0.8mm pitch(Straight-Wall) | • 60° thread &0.6mm pitch(Straight-Wall)• 60° thread &0.9mm pitch(Straight-Wall) | • 60° thread &0.6mm pitch(Straight-Wall)• 35° thread &0.8mm pitch(Straight-Wall) |
| Implant Design | Straight-walledimplant body | Straight-walledimplant body | Straight-walledimplant body |
| Self TappingFeature | Integrated cuttingflutes with apicaltaper | Integrated cuttingflutes with apicaltaper | Integrated cuttingflutes with apicaltaper |
| Implant Surface | Full OSSEOTITE® | Full OSSEOTITE® | Full OSSEOTITE® |
| Color-Coding | • Anodized SeatingSurface• Color-CodedLabeling | • Anodized SeatingSurface• Color-CodedLabeling | • Anodized SeatingSurface• Color-CodedLabeling |
| Packaging | Packaged in steriletray with coverscrew | Packaged in steriletray with cover screw | Packaged in steriletray with coverscrew |
| Sterilization | Sterile (GammaIrradiation) | Sterile (GammaIrradiation) | Sterile (GammaIrradiation) |
| Shelf Life | 5 Years | 5 Years | 5 Years |
| ImplantPlacementProtocol | Per BIOMET 3iSurgical CatalogCATSM | Per BIOMET 3iSurgical CatalogCATSM | Per BIOMET 3iSurgical CatalogCATM2 |
| Implant/AbutmentMatingConnection | Internal HexagonConnection | External HexagonConnection | External HexagonConnection |
| MatingComponents | All BIOMET 3iCertain®RestorativeComponents | All BIOMET 3iExternal HexRestorativeComponents | All BIOMET 3iExternal HexRestorativeComponents |
Performance Data:
Clinical Data:
BIOMET 31 has conducted Design Verification Testing according to ISO 14801:2007 "Dentistry – Dynamic Fatigue Test for Endosseous Dental Implants'' on the OSSEOTITE® 2 Dental Implants under this submission. All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs commercially in the marketplace. Performance testing data indicates that changes to the predicate device are safe and effective for its intended use and it demonstrate to be substantially equivalent. Bench Testing conducted demonstrates that the proposed device meets the mechanical properties recommendations by FDA and ISO Standards.
Two clinical reports on OSSEOTITE® 2 Dental Implants are included with this submission:
- "Insertional Torque Force, Osseotite 2 Placement Data, ● Pressure Necrosis" dated September 21st, 2011. This report provides background information on the thread design for the OSSEOTITE® 2 Dental Implants and a summary of two clinical projects where insertion torque forces are measured. The report includes an analysis of the actual insertion torque forces
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K111216
for this implant design, the success of the implants at a defined follow-up time point post loading, and a review of the implant failures and their baseline torque values. Additionally, the subject of pressure necrosis that has been alluded with implant placement procedures associated with high insertion torque forces is discussed.
- "BIOMET 3i Insertion Torque Report", dated November 10, . 2011. This report provides an overview of the implant placement experience data for the OSSEOTITE® 2 Dental Implants, including a tabulation of individual insertion torque values and implant failures.
The following FDA Guidance Document for this type of product was Performance Standards: utilized in this submission: "Guidance for Industry and FDA Staff: -Special Controls Class II - Root Form Endosseous Dental Abutment/ Implant". Also, Testing was conducted following ISO standard 14801:2007 Dentistry -- Implants - "Dynamic fatigue test for endosseous dental implants". The test articles met all predetermined acceptance criteria.
The OSSEOTITE® 2 Dental Implants included in this submission have the same intended use, indications for use, technological characteristics, and principles of operation as previously cleared BIOMET 3i OSSEOTITE Certain® Internal and External Connection Implants per the 510(k) numbers referenced in the Predicate Devices section above.
Refer to the following substantial equivalence data table:
| Predicate OSSEOTITE IIMODEL XIFOSSXXX(Internal Hex)K100724 | PredicateOSSEOTITE; OSSEOTITENT; XP; TG Implant(s)(External Hex)K063286 | ProposedOSSEOTITE® 2 DentalImplant(s)(External Hex)K111216 |
|---|---|---|
| Intended for surgical placementin the upper or lower jaw toprovide a means for prostheticattachment. | Intended for surgicalplacement in the upper orlower jaw to provide ameans for prostheticattachment. | Intended for surgicalplacement in the upperor lower jaw to providea means for prostheticattachment. |
| Intended for single toothrestorations and in partially orfully edentulous spans withmultiple single teeth utilizingdelayed or immediate loading,or as a terminal or intermediaryabutment for fixed orremovable bridgework, and toretain overdentures. | Intended for single toothrestorations and in partiallyor fully edentulous spanswith multiple single teethutilizing delayed orimmediate loading, or as aterminal or intermediaryabutment for fixed orremovable bridgework, andto retain overdentures. | Intended for singletooth restorations andin partially or fullyedentulous spans withmultiple single teethutilizing delayed orimmediate loading, oras a terminal orintermediary abutmentfor fixed or removablebridgework, and toretain overdentures. |
Substantial Equivalence:
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KIII 206
| retain overdentures. | |||
|---|---|---|---|
| Provide immediate functionwhen good primary stability isachieved with appropriateocclusal loading to restorechewing function. | Provide immediate functionwhen good primarystability is achieved withappropriate occlusalloading to restore chewingfunction. | Provide immediate functionwhen good primary stability isachieved withappropriate occlusalloading to restorechewing function. |
Conclusion:
OSSEOTITE® 2 Dental Implants and predicate designs have the same intended use, indications for use, similar technological characteristics, and principles of operation. The major technological difference between the OSSEOTITE® 2 Dental Implants and its predicates is:
- The ONLY change is the modification of the abutment . connection from an internal feature to an external hex engagement.
The differences noted above do not present new issues of safety or effectiveness for the OSSEOTITE® 2 Dental Implants.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing people or services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 .
Ms. Martha I. Garay Senior Regulatory Affairs Specialist BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
NOV 1 8 2011
Re: K111216
Trade/Device Name: OSSEOTTE® 2 - Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 10, 2011 Received: November 14, 2011
Dear Ms. Garay:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Garay
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ph for
Anthony D. Watson, B.S., M.S., M.B.A. 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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віомет зі Special 510(k) Premarket Notification - OSSEOTITE® 2 Dental Implants
Indications for Use
510(k) Number (if known): K111216
Device Name: OSSEOTITE® 2 –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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE® 2 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
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/7/Picture/13 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature above the text "(Division Sign-Off)". The document also includes the division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. The 510(k) Number is K111216 and the date 4/29 is at the bottom right.
§ 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.