HI BOND NON-PRECIOUS CERAMIC ALLOY

K992881 · Matech, Inc. · EJH · Nov 19, 1999 · Dental

Device Facts

• Record ID: K992881
• Device Name: HI BOND NON-PRECIOUS CERAMIC ALLOY
• Applicant: Matech, Inc.
• Product Code: EJH · Dental
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2

Intended Use

This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.

Device Story

Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a mixture of nickel and chromium. It is intended for use by dentists in the fabrication of custom-made dental restorations, specifically porcelain veneers. The alloy serves as the structural substrate for the porcelain veneer, which is then applied to a patient's tooth. The device is used in a dental clinical or laboratory setting to create prosthetic dental appliances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Base metal alloy consisting of a mixture of nickel and chromium. Class II dental device.

Indications for Use

Indicated for use by dentists in the fabrication of custom-made dental devices, such as porcelain veneers for teeth.

Regulatory Classification

Identification

A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Mr. Paul L. Saxton Manager Education and Technical Service Matech, Inc. 13010 San Fernando Road Sylmar, CA 91342

K992881 Re : Hi Bond Non-Precious Ceramic Alloy Trade Name: Requlatory Class: II Product Code: EJH Dated: Undated Received: August 26, 1999

Dear Mr. Saxton:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, 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

{1}------------------------------------------------

Page 2 - Mr. Saxton

obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation
the Act for devices under the Electronic Productions the Act for devices under the breakers or regulations.

This letter will allow you to begin marketing your device as t This letter will allow you conrest motification. The FDA described in your SFUN, prematios of your device to a legally finding of substancial equivalence of for your with marketed predicate device rebares in spoceed to the market.

If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 on vices), please contact the Office of villo diagnostic devices), proads othonally, for questions on Compilance at (501) 531 ising of your device, please contact che promotion and adversible go also, Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Intormation on your responsible manufacturers Assistance oblained from the bivibion of 630-2041 or [phone] or at i at Its coll-free hamber (o://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

{2}------------------------------------------------

## Matech, inc.

[phone] [phone] Fax: [phone]

13010 San Femando Rd., Sylmar, CA 91342, U.S.A.

Document #: B 045935

K992881 510 (k) Number (if known): . Device Name: Hi Bond Non-Precious Ceramic Alloy 510 (k) Request Matech, Inc.

Indications For Use:

- Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium
- Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
- C-Classifcation: Class II

Sincerely,

Paul Leslator

ul L. Saxton Manager Matech, Inc. 13010 San Fernando Rd. Sylmar, Ca 91342

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Runa

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _