PRO-GLASS

K991844 · Cad Cam Ventures · EIH · Jul 21, 1999 · Dental

Device Facts

• Record ID: K991844
• Device Name: PRO-GLASS
• Applicant: Cad Cam Ventures
• Product Code: EIH · Dental
• Decision Date: Jul 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indicated usage for this product is as a machinable ceramic for use in the construction of ceramic Fixed Restorations.

Device Story

Pro-Glass is a machinable ceramic material intended for the construction of fixed dental restorations. It is processed via CAD/CAM systems to create dental prosthetics. The device is used in dental laboratories or clinical settings by dental professionals to fabricate crowns, bridges, or other fixed restorations. The final ceramic output provides a restorative solution for patients requiring dental repair. The device is intended for prescription use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Machinable ceramic material designed for CAD/CAM dental restoration fabrication. No specific ASTM standards, energy sources, or software algorithms are described in the provided documentation.

Indications for Use

Indicated for use as a machinable ceramic material for the fabrication of ceramic fixed dental restorations.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 1999

Mr. Ron Fishell CAD CAM VENTURES 3301 Conflans Road, Suite 104 Irving, Texas 75061

K991844 Re : Trade Name: Pro-Glass Regulatory Class: II EIH Product Code: Dated: May 26, 1999 May 28, 1999 Received:

Dear Mr. Fishell:

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 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 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. Fishell

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.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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Page 4

510(k) Number (if known): K991844

Device Name: Pro Glass

Indications For Use:

11.00 .

> The indicated usage for this product is as a machinable `ceramic for use in the construction of ceramic Fixed Restorations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-the-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

| | <div><i>Suoar Rinas</i></div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | <i>10991844</i> |