OPC LOWWEAR PORCELAIN

K982377 · Jeneric/Pentron, Inc. · EIH · Aug 18, 1998 · Dental

Device Facts

• Record ID: K982377
• Device Name: OPC LOWWEAR PORCELAIN
• Applicant: Jeneric/Pentron, Inc.
• Product Code: EIH · Dental
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 µm, with a crystal size range between 1-4 µm. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.

Device Story

OPC LowWear™ Porcelain is a dental ceramic material used by dental professionals for fabricating all-ceramic fixed prosthodontics. The device consists of translucent porcelain applied in thin layers over pressed ceramic cores (OPC pellets). The material features a specific leucite crystal size (average 2-3 µm) within a glassy matrix, designed to reduce abrasion against opposing natural dentition compared to conventional porcelains with larger crystal sizes. The device is used in a clinical or laboratory setting to restore tooth structure via crowns, veneers, or inlays/onlays. The clinical benefit is improved wear compatibility with opposing teeth.

Clinical Evidence

No clinical trials were performed. Evidence consists of independent bench testing conducted by Dr. Shiro Suzuki at the University of Alabama at Birmingham, comparing the abrasion characteristics of the device's leucite crystal size (1-4 µm) against conventional porcelains (1-40 µm).

Technological Characteristics

Dental porcelain material; glassy matrix containing leucite crystals with an average size of 2-3 µm (range 1-4 µm). Designed for application over pressed ceramic cores. Class II device.

Indications for Use

Indicated for use in all-ceramic fixed prosthodontics, including full crowns, veneers, and inlays/onlays, when used with Optimal Pressable Ceramic (OPC) pellets.

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)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Mr. Murray G. Gamberg Quality Systems Director Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

Re : K982377 OPC Low wear™ Porcelain Trade Name: Requlatory Class: II Product Code: EIH Dated: June 24, 1998 Received: July 8, 1998

Dear Mr. Gamberg:

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 legally marketed predicate 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 qeneral controls provisions of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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

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

Page 2 - Mr. Gamberg

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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"(21CFR 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/dsma/dsmamain.html" .......

Sincerely yours,

S. Dutman for

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

Enclosure ---------

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

| 510(k) Number (if known): | K982377 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: OPC LowWear™ Porcelain

Indications for Use:

OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 µm, with a crystal size range between 1-4 µm. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.

Sason Rusk

s (0(k) Number

and General Hospital Devices , circus of Dental, Infection Control, (HO-ugis noisi (1)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

..............................................................................................................................................................................

OR

Over-the Counter Use

(Optional Format 1-2-96)