FRIALIT-2 PROTECT ABUTMENT

K974628 · Friatec AG · DZE · Mar 11, 1998 · Dental

Device Facts

• Record ID: K974628
• Device Name: FRIALIT-2 PROTECT ABUTMENT
• Applicant: Friatec AG
• Product Code: DZE · Dental
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The FRIALIT-2 ProTect Abutment is intended for use as a temporary abutment system for short and longer term provisionilization of the FRIALIT-2 implant system, and a provisional abutment for screw. retained crowns or bridges.

Device Story

FRIALIT-2 ProTect Abutment functions as temporary abutment system for FRIALIT-2 dental implant system; facilitates short and long-term provisionalization; serves as provisional abutment for screw-retained crowns or bridges. Used in clinical dental settings by licensed dentists/prosthodontists. Device provides structural interface between dental implant and provisional restoration during healing or interim treatment phases. Benefits patient by maintaining soft tissue contour and allowing functional/aesthetic provisional restoration prior to final prosthetic placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary dental abutment system for FRIALIT-2 implant platform. Form factor designed for screw-retained provisional crowns or bridges. Materials and sterilization methods not specified in provided text.

Indications for Use

Indicated for use as a temporary abutment system for short and long-term provisionalization of the FRIALIT-2 implant system and as a provisional abutment for screw-retained crowns or bridges.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three figures representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR | | 1998

FRIATEC AG ·C/O Mr. Robert Joel Slomoff Consultant for FRIATEC AG 9229 Cranford Drive Potomac, Maryland 20854

Re : K974628 Frialit-2 Protect Abutment Trade Name: Requlatory Class: III Product Code: DZE Dated: December 10, 1997 December 11, 1997 Received:

Dear Mr. Slomoff:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with ........ the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Slomoff

This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.97 TUE 12:13 PM ROBERT JOEL SLOWOFF

FRI 12:01 FAX [phone]

3019831708 FAX NO.

FDA/ODR/DDIGD

Pago / of /

K97-4628 5 10(k) Number (if known): Pending

FRIALIT-2 ProTect Abutment Device Name:

Indications For Use:

12/19/97

INDICATIONS:

The FRIALIT-2 ProTect Abutment is intended for use as a temporary abutment system for short and longer term provisionilization of the FRIALIT-2 implant system, and a provisional abutment for screw. retained crowns or bridges.

(PLEASE DO NOT VRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deedee W. Sheppard
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 13974628 510(k) Number .

\$

Prescription Use OR (Per 21 CFR 801-109) -

Over-The-Counter Use ------

(Optional Format 1-2-96,