The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Device Description

The 3i Patient-Specific Dental Abutments are designed to match an individual patient. Since each 3i Patient-Specific Dental Abutment is manufactured to match a particular patient according to the doctor's requirements, a specific device description is not possible. However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and the study details as requested. It's important to note that the provided text is a 510(k) summary for a dental abutment, which is a physical device, not a software or AI-driven system. Therefore, many of the typical AI/software study criteria (like experts, ground truth, training sets, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 3i Patient-Specific Dental Abutments (K032263).
Intended Use	Intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. For single and multiple tooth prostheses in mandible or maxilla. Screw or cement retained.
Technological Characteristics	Contains features and functions similar to the currently available 3i Patient-Specific Dental Abutments (K032263).
Performance Standards	Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act. (Implies meeting general safety and effectiveness requirements by demonstrating equivalence).

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

This information is not applicable to this type of device submission. The 510(k) for a physical dental abutment relies on demonstrating equivalence to a predicate device, often through design comparison, material testing, and sometimes bench testing, rather than a clinical "test set" with patient data in the way an AI/software device would. The document does not specify any sample sizes for tests.

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

This information is not applicable. The concept of "ground truth" established by experts for a test set is relevant to diagnostic or interpretive AI systems, not a physical dental abutment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are used in studies involving human interpretation or decision-making, especially in AI-assisted diagnostics, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which does not apply to 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. The device is a physical dental abutment; there is no AI algorithm to evaluate in a standalone capacity.

7. The Type of Ground Truth Used

This information is not applicable in the context of this device. For a physical device, "ground truth" might refer to engineering specifications, material properties, or functional benchmarks, which are evaluated through design review and potentially bench testing, rather than expert consensus on data interpretation.

8. The Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning models, which are not relevant to this physical medical device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set for an AI model, the method of establishing ground truth for it is irrelevant.

Summary of Device Acceptance & Study Information (based on provided text):

The acceptance of the "3i Patient-Specific Dental Abutments" is primarily based on demonstrating substantial equivalence to an already legally marketed predicate device (3i Patient-Specific Dental Abutments, K032263). The study performed, implicitly, is a comparison of the new device's design, materials, and intended use against the predicate device to show that it raises no new questions of safety or effectiveness.

The document states: "The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263]." and explicitly concludes: "The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 3i Patient-Specific Dental Abutments."

This means the "study" for acceptance was a comparison study against a predicate device, focusing on design, materials, and intended use to establish substantial equivalence, rather than a clinical trial with a "test set" for performance metrics commonly associated with diagnostic or AI devices. The FDA's decision is based on agreement that the new device is as safe and effective as the predicate.

Summary

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OCT 2 0 2005

K052648

Summary of Safety and Effectiveness

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

Submitter	Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410
Contact	Jim BanicRegulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6932Fax. 561-514 6316Email jbanic@3implant.com
Date Prepared	September 20, 2005
Device Name	Patient-Specific Dental Abutments
Classification Name	Dental Abutments
DeviceClassification	Class IIDental Devices Panel21 CFR § 872.3630
PredicateDevices	3i Patient-Specific Dental AbutmentsK032263
Performance	Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act.
Device Description	The 3i Patient-Specific Dental Abutments are designed tomatch an individual patient. Since each 3i Patient-SpecificDental Abutment is manufactured to match a particularpatient according to the doctor's requirements, a specific

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device description is not possible.

K65 2648

However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.

The 3i Patient-Specific Dental Abutments and Overdenture Indications for Use Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263].
Conclusion The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 31 Patient-Specific Dental Abutments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper half of the circle.

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, FLORIDA 33410

Re: K052648

Trade/Device Name: Modification to 3i Patient-Specific Dental Abutments and Overdenture Bars Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: September 20, 2005 Received: September 26, 2005

Dear Mr. Banic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed yoursed your with 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 incersate commerce proct to traylave been reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Orbu may, therefore, market the device, subject to the general approvin uppineation (The Act. The general controls provisions of the Act include controls providents of a 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 If your device to such additional controls. Existing major regulations affecting (1 Mr), it may of buryev to fines 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. Banic

Please be advised that FDA's issuance of a substantial equivalence determination does not r least oc auvrsed that 1 Dr. I termination that your device complies with other requirements mean that ITA has made a determinaregulations administered by other Federal agencies. of the Act of ally i edelar statues and rightenents, including, but not limited to: registration r ou must comply with an an e labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 067), acciity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic product radiation control provisions (Sections 531-542 of the Act); applicable, the clections proute will allow you to begin marketing your device as described 21 CFK 1000-1030. This lease will affication. The FDA finding of substantial equivalence In your Section 510(x) promaticate 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), If you desire specific advice for your are 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

fer

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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Page 1 __ of 1

Indications for Use

510(k) Number (if known):	K052648
Device Name:	3i Patient Specific Abutments

Indications for Use:

The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in The prostheses can be screw or cement retained to the the mandible or maxilla. abutment.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quorn

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K050645

Page 1 of

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.)