31 T3 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.

31 T3® 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

The 31 T3® External Hex Dental Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implans are offered with or without a nano-scale discrete crystalline deposition (DCD®) of calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in either parallel walled or tapered body geometries. The implants are available in various platform options and feature an external hex connection for mating with associated Biomet 3i™ external connection restorative components. The implants are offered in a variety of diameters (3.25mm -6.0mm) and lengths (Parallel walled: 6.5mm - 18.0mm, Tapered: 8.5mm - 15.0mm) to accommodate varying patient anatomy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the 3i T3® External Hex Dental Implants. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the input provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Pre-determined acceptance criteria for fatigue testing in accordance with ISO 14807:2007.	"The subject devices met the predetermined acceptance criteria." (Specific numerical values for acceptance criteria or performance are not provided in the text).

Note: The document states that the devices met the acceptance criteria, but it does not specify what those criteria were (e.g., minimum cycles to failure, maximum displacement) or the exact performance values achieved by the device. It only refers to "predetermined acceptance criteria" from ISO 14807:2007.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not explicitly state the sample size used for the mechanical testing. It refers to "worst case subject devices" but provides no count.
Data Provenance: The data is described as "Non-clinical testing" in the form of "mechanical testing." It is implied to be laboratory testing conducted by the manufacturer (BIOMET 3i™) to support the 510(k) submission. No information on country of origin of the data is provided, nor is it described as retrospective or prospective human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable. The "ground truth" for this type of non-clinical mechanical testing is the established standard (ISO 14807:2007) and the physical measurements/observations during the test. There were no human experts involved in establishing a "ground truth" for this mechanical performance study in the way one would for clinical imaging or diagnostic studies.

4. Adjudication Method for the Test Set:

Not Applicable. As this was a mechanical test against an ISO standard, there would not be an adjudication method in the context of human expert review or consensus. The results would be objectively measured and compared to the standard's requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical mechanical fatigue test, not a clinical study involving human readers or patient cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This device is a dental implant, not a software algorithm or AI system. The concept of "standalone performance" for an algorithm is not relevant here. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:

Standard-based performance specifications. The "ground truth" for this non-clinical testing is the performance requirements and methodologies outlined in ISO 14807:2007 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). The device's performance was compared against these established mechanical engineering standards.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" referenced in this context. The study is a mechanical performance test, not a machine learning or AI model development project.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K133049

JAN - 8 2014

3i T3® External Hex Dental Implants 510(k) Summary December 18, 2013

BIOMET 3:TM 1. Company: 4555 Riverside Drive Palm Beach Gardens, Florida 33410 (561) 776-6700
- Chris McKee Contact: Regulatory Affairs Manager
Proprietary Trade Name: 3i T3® External Hex Dental Implants II.
III. Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
Class II IV. Classification:
DZE V. Product Code(s):

VI. Reason for 510(k)

The purpose of this 510(k) was to expand BIOMET 3i™'s dental implant product line by adding dental implants with a multi-level surface topography like the existing 3i T3® Dental Implants but with an external connection like other BIOMET 3i™ product lines.

VII. Product Description

VIII. Indications

31 T3® 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.

3i T3® 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.

Summary of the Technological Characteristics IX.

The subject devices provide additional implant options for connection to existing Biomet 3i™ external hex restorative components. The primary change from the predicate 3i T3® devices in K 122300 is that the connection geometry is an external connection instead of an internal

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connection. The external connection is the same as the other predicate external connection dental implants. The materials, implant body designs (tapered and parallel walled), surface treatments and sizes are the same as the listed predicate devices.

X. Identification of Legally Marketed Devices

The design features, materials and indications for use of the subject devices are substantially equivalent to the predicate devices noted below.

. 3i T3 Dental Implants (K122300)
OSSEOTITE® 2 External Hex Parallel Walled Dental Implants (K111216) .
OSSEOTITE® External Hex Dental Implants (K063286) .

Discussion of the Non-Clinical Testing XI.

Non-clinical testing in the form of mechanical testing was performed on the worst case subject devices in the form of fatigue testing in accordance with ISO 14807:2007. The results were compared to the previously listed predicate devices in K063286. The subject devices met the predetermined acceptance criteria.

XII. Conclusions

Based on the test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2014

BIOMET 3 TM Mr. Chris McKee Regulatory Affairs Manager 4555 Riverside Drive Palm Beach Gardens, FL 33410

Re: K133049

Trade/Device Name: 3i T3® External Hex Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 18, 2013 Received: December 19, 2013

Dear Mr. McKee:

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 - Mr. McKee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.

Kwame O. Ulmer -S

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K133049

Device Name: 3i T3® External Hex Dental Implants

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.