SFB & CFB IMPLANTS by NOBEL BIOCARE AB

Nobel Biocare's SFB and CFB implants are endosseous implant 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. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Device Description

Nobel Biocare TiUnite® Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The SFB and CFB implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

Nobel Biocare SFB and CFB implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria. The document is a 510(k) summary for dental implants, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

The document describes:

Device: SFB & CFB Implants
Intended Use: Endosseous dental implants to support prosthetic devices.
Predicate Devices: TiUnite Implants (K050705) and Groovy Implants (K050258).

There is no mention of:

Specific acceptance criteria.
Performance metrics (e.g., accuracy, sensitivity, specificity).
Any study design (e.g., sample size, data provenance, ground truth establishment, expert adjudication).
MRMC or standalone AI studies.

The letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to the predicate devices for its stated indications for use. This process relies on demonstrating similarity to already legally marketed devices, not necessarily on new performance studies against predefined acceptance criteria for the new device as would be the case for novel AI/ML devices or other complex technologies requiring extensive performance validation.

Summary

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K661003

1.4 510(k) Summary of Safety and Effectiveness

JUN 300 2006

Submitted by:	Herbert CraneDirector Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 5074
Facsimile:	(714) 282-9023
Date of Submission:	April 10, 2006
Classification Name:	Endosseous Dental Implant (21 CFR 872.3640)
Trade or Proprietary or Model Name:	SFB & CFB Implants
Legally Marketed Device(s):	TiUnite Implants (K050705)Groovy Implants (K050258)

Device Description:

Indications for Use:

Nobel Biocare's SFB and CFB implants are endosseous implant 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. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2006

Nobel Biocare AB C/O Mr. Herbert Crane Director of Regulatory Affairs Nobel Biocare USA. LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Rc: K061003

Trade/Device Name: SFB & CFB Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 10, 2006 Received: April 11, 2006

Dear Mr. Crane:

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 - Mr. Crane

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 (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.

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 vour 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

Silon Kuno

Chiu-Li, Ph.D.

Chiu Lin. Ph.D. Child Liller 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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K061003 510(k) Number (if known):

Device Name: SFB & CFB Implants

Indications For Use:

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

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)

Shashi Panwar

of Anasthesiology, General Hospital in Contici. Dental Devices

Page 1 of 1

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.