BELLEGLASS HP OPAQUE 2

K013375 · Kerr Dental Materials Center · EBF · Oct 29, 2001 · Dental

Device Facts

• Record ID: K013375
• Device Name: BELLEGLASS HP OPAQUE 2
• Applicant: Kerr Dental Materials Center
• Product Code: EBF · Dental
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.

Device Story

belleGlass HP Opaque 2 is a dual-cured composite material; used by dental professionals in clinical or laboratory settings for crown and bridge fabrication; functions as a metal masking agent to cover metal substrates; provides a durable base for composite restorations; applied during restorative procedures to improve aesthetic outcomes by masking underlying metal; used in conjunction with the belleGlass HP heat and pressure system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cured composite resin material; functions as a metal masking agent; intended for use in crown and bridge fabrication; chemical composition consistent with dental restorative resins.

Indications for Use

Indicated for masking metal substrates in crown and bridge dental restorations and for use as a material for reinforcement or bulk build-up of restorations.

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

• Kerr Corporation, Opaker

Submission Summary (Full Text)

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OCT 2 9 2001

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font.

K013375

### RON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

#### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: October 2001

#### Device Name:

- Trade Name belleGlass HP Opaque 2 .
- Common Name Metal Masking Agent .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

#### Devices for Which Substantial Equivalence is Claimed:

. Kerr Corporation, Opaker

#### Device Description:

belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations. belleGlass HP Opaque 2 is also used with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

#### Intended Use of the Device:

The intended use of belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.

#### Substantial Equivalence:

BelleGlass HP Opaque 2 is substantially equivalent to other legally marketed devices in the United States. BelleGlass HP Opaque 2 functions in a manner similar to and is intended for the same use as the original Opaker formulation that is currently manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## OCT 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerr Dental Materials Center Ms. Colleen Boswell Director, Corporation Compliance A Division of Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K013375

Trade/Device Name: BelleGlass HP Opaque 2 Regulation Number: 872.3690 Regulation Name: Metal Masking Agent Regulatory Class: II Product Code: EBF Dated: October 10, 2001 Received: October 11, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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#### Page 2 - Ms. Boswell

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

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

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# K013375

#### Section I

## Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Materials Center

510(k) Number (if known): *K013375*

Device Name: BelleGlass HP Opaque 2

Indications For Use:

*BelleGlass HP Opaque 2* is dual cured composite material used to mask metal substrates in
crown and bridge work and other materials used for reinforcement or bulk build-up of
restorations.

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *K013375*

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)