NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS by NOBEL BIOCARE AB

Nobel Biocare's NobelPerfect Conical Connection Hexagonal implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelPerfect Conical Connection Hexagonal implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection Hexagonal implants can be used in splinted or non-splinted applications. The NobelPerfect Conical Connection Hexagonal implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Device Description

NobelPerfect Conical Connection Hexagonal implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelPerfect Conical Connection Hexagonal implants are similar in design to the implants cleared under NobelPerfect, Conical Connection, K062936. The predicate internal square was changed to internal hexagonal connection.

AI/ML Overview

The provided text is a 510(k) summary for the NobelPerfect Conical Connection Hexagonal dental implant. This document is a regulatory submission to the FDA, primarily focused on demonstrating substantial equivalence to a predicate device. It certifies that the device meets the regulatory requirements for safety and effectiveness through equivalence to an already approved device. Therefore, it does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study would for a novel device.

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not provide a table of acceptance criteria or reported device performance in the context of a standalone clinical study. The device's "performance" is implicitly deemed acceptable by its substantial equivalence to the predicate device, NobelPerfect Conical Connection (K062936).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There is no test set or related data described from a clinical study for this device. The submission relies on demonstrating equivalence in design and materials to a previously cleared device.
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): Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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: Not applicable. This document pertains to a dental implant, not an AI software or imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth, in the context of a clinical study or AI performance evaluation, is not relevant to this 510(k) submission which relies on substantial equivalence.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a physical dental implant and not an AI/machine learning model.
9. How the ground truth for the training set was established: Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary of the Device and Submission:

The NobelPerfect Conical Connection Hexagonal implant is a screw-shaped dental implant intended to support prosthetic devices. The 510(k) submission establishes its substantial equivalence to the legally marketed device, NobelPerfect Conical Connection (K062936). The primary change in the new device is the internal connection from a square to a hexagonal design. Regulatory clearance is based on the premise that this design change does not raise new questions of safety or effectiveness, as the overall intended use and fundamental technological characteristics remain comparable to the predicate device. Therefore, the "acceptance criteria" were met by demonstrating this substantial equivalence through comparison to the predicate, rather than through a new, independent clinical performance study.

Summary

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K07 2980

1.4 510(k) Summary of Safety and Effectiveness

Submitted by:	Kam Leung, Ph.D., RACSenior Regulatory Affairs Specialist
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887	DEC 2 0 2007
Telephone:	(714) 282-4800, ext. 7842
Facsimile:	(714) 282-9023
Date of Submission:	October 22, 2007
Classification Name:	Endosseous dental abutment & implant (21CFR872.3630, 21CFR872.3640)
Trade or Proprietaryor Model Name:	NobelPerfect Conical Connection Hexagonal

Legally Marketed Device(s): NobelPerfect Conical Connection (K062936)

Device Description:

Indications for Use:

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of a staff with three intertwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

Nobel Biocare AB C/O Kam Leung, Ph.D., RAC Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K072980

Trade/Device Name: NobelPerfect Conical Connection Hexagonal Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 29, 2007 Received: November 30, 2007

Dear Dr. Leung:

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.

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Page 2 - Dr. Leung

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 (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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smer Ruase
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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Indication for Use 1.3

510(k) Number (if known): KO 72980

Device Name: NobelPerfect Conical Connection Hexagonal

Indication For Use:

Susan Runner

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

510(k) Number:

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 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.