BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Device Description

BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°.

AI/ML Overview

The provided document (K110565) describes a traditional 510(k) premarket notification for a medical device called "BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for novel performance claims.

Based on the information provided, here's what can be extracted and what is not present:

1. Table of acceptance criteria and reported device performance:

The document states: "Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Performance testing was based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the quantitative reported device performance are not detailed in this summary. Instead, it refers to a "comparison between proposed and predicate implant/abutment systems" and implies meeting established baselines.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Based on Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Abutments.	The results of performance testing were "equal or better" than the established acceptance criteria, using predicate device testing as a baseline. Specific quantitative data is not provided in this summary.
Baseline performance of predicate implant/abutment systems (K020646, K053654, K023113).	Demonstrated performance "equal or better" than the predicate devices for the relevant performance parameters (e.g., mechanical strength, durability). Specific quantitative data is not provided in this summary.
Compatibility testing for the abutment (as per the statement "Compatibility testing for the abutment will be performed every 6 months").	Initial compatibility testing was successful, allowing for market clearance. Ongoing compatibility testing is planned every 6 months.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The document mentions "Performance testing was conducted," but it doesn't specify the number of samples used for this testing or the origin of any data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided for this type of device submission. This device is a mechanical abutment, not an AI/software device that requires expert ground truth for interpretation or diagnosis. The performance evaluation would involve engineering and material testing, not clinical expert review for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable and not provided. As above, this is a mechanical device, not an AI/software product requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI systems where human readers interpret cases. This device is a physical dental abutment.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant.

7. The type of ground truth used:

For this device, the "ground truth" would be established through engineering and materials testing standards (e.g., fatigue testing, static load testing, dimensional accuracy measurements) as per the "Class II Special Controls Guidance Document." It relies on objective, measurable physical properties and mechanical performance, not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices. The acceptance criteria themselves serve as the definition of acceptable "truth" for performance.

8. The sample size for the training set:

This information is not applicable and not provided. This is a physical device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:

This information is not applicable and not provided. There is no "training set" for this physical device.

In summary:

The provided document describes a 510(k) submission for a dental abutment, demonstrating substantial equivalence to predicate devices primarily through performance testing based on established guidance documents. It does not contain the detailed information typically found in AI/software device submissions regarding acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or human-in-the-loop studies. The "study" here refers to engineering performance testing against regulatory guidance and predicate device baselines, not a clinical study with human readers or AI algorithms.

Summary

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BIOMET 31, Traditional 510(k) Premarket Notification - BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection

BIOMET 3i

SEP - 1 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 Registration Number:	1038806
Contact:	Jose E. CabreraSr. Manager, Regulatory AffairsBIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6840Fax. 561-514 6316Email jose.cabrera@biomet.com
Date Prepared:	08/27/2011
Trade/Proprietary Name:	Encode Patient Specific Abutment with Nobel Replace Connection
Common/Usual Name:	Dental Implant Abutment
Classification Name:	Abutment, implant, dental, endosseous
Device Classification/ Code:	Class II 21 CFR §872.3630 / NHA
Predicate Device:	K020646, Nobel Replace HA Coated ImplantK053654, Atlantis Abutment for Nobel Replace InterfaceK023113, Replace TiUnite Endosseous Implant
Performance Testing:	Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental

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BIOMET 3i,

Traditional 510(k) Premarket Notification – BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection

Abutments. Performance testing was based on acomparison between proposed and predicatimplant/abutment systems. The results were equal obetter than established acceptance criteria, wherpredicate testing was used as a baseline. Compatibilittesting for the abutment will be performed every 6months.
Device Description:	BIOMET 3i Encode Patient Specific Abutment forNobel Replace Connection can be compared to currentEncode Patient Specific abutments. The change to thisdevice is only to the connection that is intended tointerface which is identical to the interface found on theNobel Replace HA Coated Implant. This feature doesnot modify the intended functionality of theimplant/abutment system. This device is also intendedfor dental laboratories to provide limited design input tomatch the anatomical requirements of the patient.Maximum angulation for the abutment is limited to 15°.
Indications for Use:	BIOMET 3i Dental Abutments are intended for use asaccessories to endosseous dental implants to support aprosthetic device in a partially or completely edentulouspatient. A dental abutment is intended for use to supportsingle and multiple tooth prosthesis, in the mandible ormaxilla. The prosthesis can be screw retained or cementretained to the abutment.
TechnologicalCharacteristics	BIOMET 3i Encode Patient Specific Abutment forNobel Replace Connection is milled from titaniumalloy, is attached to a dental implant and is indicated forthe same intended use as the predicated devicesreference within this pre-market notification.
Conclusion:	BIOMET 3i Encode Patient Specific Abutment forNobel Replace Connection is substantially equivalent tothe legally marketed predicates

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Mr. Jose E. Cabrera Senior Regulatory Affairs Manager BIOMET 3i. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

SEP - 1 2011

Re: K110565

Trade/Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 29, 2011 Received: August 31, 2011

Dear Mr. Cabrera:

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. Cabrera

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 l'ederal 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 (QS) 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/Industrv/default.htm.

Sincerely yours.

hh 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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Indications for Use

510(k) Number (if known): KIlO565

Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection

Indications for Use: BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(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 HospitalInfection Control, Dental Devices
510(k) Number:	K110565

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)