BELLEGLASS HP ENAMEL REPAIR MATERIAL

K971762 · Sybron Dental Specialties, Inc. · EBF · Sep 12, 1997 · Dental

Device Facts

• Record ID: K971762
• Device Name: BELLEGLASS HP ENAMEL REPAIR MATERIAL
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.

Device Story

BelleGlass HP Enamel Repair Material is a dental composite resin used for minor adjustments or repairs to appliances during fabrication. It is a reformulation of the existing heat and pressure cure material, modified by the addition of a photoinitiating agent (<1%) to enable light curing. This modification improves material stability during transfer to the heat and pressure curing device by reducing paste deformation and flow. The device is used in commercial dental laboratories by technicians. The material is applied to the appliance, light-cured for stability, and then processed via the standard heat and pressure curing system. The output is a repaired dental appliance. Benefits include improved handling and durability during the fabrication process.

Clinical Evidence

No clinical data. Evidence consists of bench testing comparing the dual-cure material to the predicate heat and pressure cure material. Biocompatibility testing was performed by Toxicon Corporation, including Agar Diffusion Test (USP) for cytotoxicity and Salmonella Typhimurium reverse mutation assay (Ames test) for mutagenicity.

Technological Characteristics

Dual-cured composite resin containing a photoinitiating agent (<1%). Formulated for light-curing followed by heat and pressure curing. Biocompatibility testing conducted per ISO 10993 standards.

Indications for Use

Indicated for use in dental laboratories for minor adjustments or repairs to composite-based crowns and bridgework fabricated using the BelleGlass HP system.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• BelleGlass HP Heat and Pressure Cure Enamel Repair Material

Reference Devices

• BelleGlas HP Dental Laboratory Crown and Bridge Fabrication System (K95533)

Submission Summary (Full Text)

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Ka7176a

SEP 1 2 1997

Page 1 of 2

# 510 ( k ) Summary

## Statement of Safety an Effectiveness

# BelleGlass HP Enamel Repair Material

Submitter

Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 [phone] - Phone [phone] - FAX William R. Pike - Contact Person

#### Device Name

Trade Name: BelleGlass HP Enamel Repair Material Common Name: Dual Cured Composite Crown and Bridge Fabrication Material Classification Name: Tooth shade resin material, Class II, 21 CFR 872.3690

Devices for which Substantial Equivalence is Claimed

BelleGlass HP Heat and Pressure Cure Enamel Repair Material ( Kerr Corporation )

#### BACKGROUND

Kert/Dental Materials Center currently manufactures a product marketed under the Tradename BelleGlas HP Dental Laboratory Crown and Bridge Fabrication System ( 510 ( k ) Reference K95533) ). It is used in commercial dental laboratories to fabricate composite based crowns and bridgework. This product has been on the market since March, 1996. A component material in the current product is a heat + pressure cured enamel repair to be used for minor adjusments or repairs to appliances damaged during processing. BelleGlass Dual Cure Enamel Repair Material is simply a reformulation of the heat and pressure cure material to allow the material to be light cured so that it is more stable during the transfer to the Heat + Pressure Curing Device. This is a product modification based on requests from customers for a more durable, with respect to paste deformation and flow, during the transfer procedure.

#### BelleGlass HP Dual Cure Enamel Repair Material

A very small amount of photoinitiating agent ( < 1 % ) was added to the formula and the directions will be rewritten to include the light cure step when using the enamel repair materials.

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# SAFETY

The reformulated product was reexamined using two of the test protocols specified in the ISO 10993 Biocompatibility Testing Guidance Standard.

The testing consisted of the following:

# Independent Laboratory Evaluation by Toxicon Corporation

- A.) Cytotoxicity: Agar Diffusion Test USP
- B.) Mutagenicity: Salmonella Typhimurium REVERSE MUTATION ASSAY ( Ames Test )

# EFFICACY

Effectiveness or suitability to the intended purpose of BelleGlass HP Dual Cure Enamel Repair Material has been demonstrated by side test comparisons to the current heat and prssure cure enamel repair material. Results of this bench testing indicates that the dual cure material performs as well or better than the heat + pressure cured material. Actual results of this comparative testing is provided elsewhere in this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Mr. William R. Pike Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667

Re : K971762 Trade Name: Belleqlass HP Enamel Repair Material Regulatory Class: II Product Code: EBF Dated: July 17, 1997 Received: July 21, 1997

Dear Mr. Pike:

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 of the Act. The general controls provisions 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 current Good Manufacturing Practice requirement, 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 regulatory 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

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Page 2 - Mr. Pike

through 542 of the Act for devices under the Electronic through 542 of the Act 101 xevisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as This letter will allow you co begin motification. The FDA described in your 510 (x) promalence of your device to a legally I marketed predicate device results in a classification for your marketed predicate device robates as a proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcorris and additionally 809.10 for in regulacion (21 or origins), please contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at (301) 554 - 1010. Insuredevice, please contact the Dromotion and adversions [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercless, "ABFR 807.97) , Other general premation on your responsibilities under the Act may be firstmacion on Journal Manufacturers Assistance obcained from the bivibical 02 638-2041 or [phone] or at at its coll-free number (000) 030 fda.gov/cdrh/dsmamain.html".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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 I of 1

510 ( k ) Number : K 971762

Device Name : BelleGlass Dual Cure Enamel Repair Resin

Indications For Use : BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.

Concurrence of CDRH, Office of Device Evaluation

Swoer Ranner

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

prescription use Yes

ver-The-Counter use No