CERADIUM V NON-PRECIOUS CERAMIC ALLOY

K993572 · Matech, Inc. · EJH · Dec 13, 1999 · Dental

Device Facts

• Record ID: K993572
• Device Name: CERADIUM V NON-PRECIOUS CERAMIC ALLOY
• Applicant: Matech, Inc.
• Product Code: EJH · Dental
• Decision Date: Dec 13, 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

Ceradium V 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 veneer, which is then processed by the dental professional to restore tooth form and function. The device is used in a clinical or laboratory setting by dental professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Base metal alloy composed of nickel and chromium. Formulated for use in dental porcelain veneer fabrication. Class II medical 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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble a caduceus or a stylized representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1999

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

> K993572 Re: Ceradium V Non-Precious Ceramic Alloy Trade Name: Regulatory Class: II Product Code: EJH Dated: Undated Received: October 21, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 labeling requlation (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.fdatgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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

K993572

Document #: g 055589

510 (k) Number (if known): K993572
Device Name: Ceradium V 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.
- Classifcation: Class II C-

Sincerely,

Paul E. Seton

1 L. Saxte anager Matech, Inc. 3010 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)

Susan Runne

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

510(k) Number KM3572

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)