OPC LOW WEAR OPAQUE PORCELAIN

K993249 · Jeneric/Pentron, Inc. · EIH · Nov 29, 1999 · Dental

Device Facts

• Record ID: K993249
• Device Name: OPC LOW WEAR OPAQUE PORCELAIN
• Applicant: Jeneric/Pentron, Inc.
• Product Code: EIH · Dental
• Decision Date: Nov 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

OPC Low Wear Opaque Porcelain will be used for porcelain-fused to metal restorations on high expansion alloys by or on the order of a dentist. OPC Low Wear Opaque Porcelain contains opacifiers to cover the metal on porcelain-fused to metal restorations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment.

Device Story

OPC Low Wear Opaque Porcelain is a dental porcelain powder used by dentists to fabricate porcelain-fused-to-metal (PFM) restorations. The material is applied to metal copings to mask the underlying metal color; subsequent layers of translucent porcelain are fired over the opaque layer to complete the restoration. The formulation includes opacifiers and zinc oxide to improve bonding to the metal substrate. Zirconium, titanium, and zinc oxides are present in an inert state. The device is used in a dental office setting to restore patient dentition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powdered porcelain containing opacifiers, zinc oxide, and fluorine. Components include zirconium, titanium, and zinc oxides. Material is inert. Designed for application to high expansion metal alloys via firing process.

Indications for Use

Indicated for use as a porcelain powder bonded to metal copings to form dental restorations, specifically to cover metal restorations when used in conjunction with OPC Low Wear Porcelain (K982377).

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.

Predicate Devices

• OPC Low Wear Porcelain (K982377)
• Synspar Porcelain (K910303)

Submission Summary (Full Text)

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JEN PEN LEGAL

ফ্রী ০০১ :

K993249

NOV 2 9 1999

## 510(K) SUMMARY 20.0

OPC Low Wear Opaque Porcelain will be used for porcelain-fused to metal restorations on high expansion alloys by or on the order of a dentist. OPC Low Wear Opaque Porcelain contains opacifiers to cover the metal on porcelain-fused to metal restorations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment. We believe that OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, which have previously been approved by the FDA, are substantially equivalent. These devices are powder porcelains used for fabricating restorations. OPC Low Wear Opaque Porcelain only differs from OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, due to opacifiers being added to hide the metal of the restorations. Also, Zinc oxide has also been added to help achieve adequate.bond to the metal. Zirconium, Titanium and Zinc are all present in the porcelain as oxides. which renders them inert. The safety and effectiveness is not affected because OPC Low Wear Onague Porcelain only differs from the predicate devices by adding opacifiers to hide the metal of the restorations and Zinc Oxide help achieve adequate bond to the metal. OPC Low Wear Opaque Porcelain also contains Fluorine as does OPC Low Wear Porcelain, K982377.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 1999

Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

K993249 Re : OPC Low Wear Opaque Porcelain Trade Name: Requlatory Class: II Product Code: EIH September 27, 1999 Dated: Received: September 28, 1999

Dear Ms. Tenero:

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 regulations 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 requlation may result in requlatory 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

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Paqe 2 - Ms. Tenero

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 ene regaracion cheation" (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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510 (k) NUMBER (IF KNOWN) : K993249

OPC Low Wear Opaque Porcelain DEVICE NAME:

OPC Low Wear Opaque Porcelain is a porcelain powder, INDICATIONS FOR USE: bonded to metal copings to form dental restorations. Subsequent which will be layers of translucent porcelains will be fired on top to complete the restoration. Particularly, to be used with OPC Low Wear Porcelain, K982377 to cover the metal restoration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use W (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Suren Runne

(Division Sign-Off) Division of Dental, Infection Con and General Hospita 510(k) Number