BELLEGLASS HP MODELING GEL

K020178 · Kerr Dental Materials Center · EBG · Mar 15, 2002 · Dental

Device Facts

• Record ID: K020178
• Device Name: BELLEGLASS HP MODELING GEL
• Applicant: Kerr Dental Materials Center
• Product Code: EBG · Dental
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and sculpting layers of composites and it is to be used between layers of cured composite.

Device Story

belleGlass HP Modeling Gel is a 50% filled resin containing 0.4-micron radiopaque reinforcing fillers; functions as a flowable composite pre-wetting agent. Used by dental professionals during the fabrication of composite restorations to improve handling; reduces surface stickiness; facilitates sculpting; ensures strong intimate bonding between composite layers; prevents dilution of enamel/dentin surfaces. Application results in closer margins, stronger restorations, and improved polishability; enhances clinical efficiency and productivity.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Filled resin material; 50% filled with 0.4-micron average particle size radiopaque reinforcing fillers. Formulated as a gel similar to flowable composites. Non-electronic, mechanical dental material.

Indications for Use

Indicated for use as a pre-wetting agent for placing and sculpting composite layers and between layers of cured composite in dental restorative procedures.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• belleGlass HP Modeling Resin (Kerr Corporation)

Submission Summary (Full Text)

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K020178

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

MAR 1 5 2002

### BRON 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: January 2002

#### Device Name:

- Trade Name belleGlass HP Modeling Gel .
- Common Name Modeling Gel .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

### Devices for Which Substantial Equivalence is Claimed:

- . Kerr Corporation, belleGlass HP Modeling Resin
### Device Description:

belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.

### Intended Use of the Device:

The intended use of belleGlass HP Modeling Gel is to be used as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite.

### Substantial Equivalence:

belleGlass HP Modeling Gel is substantially equivalent to other legally marketed devices in the United States. The product marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a black and white circular logo. The logo features the emblem of the U.S. Department of Health & Human Services in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 5 2002

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K020178

Trade/Device Name: belleGlass HP Modeling Gel Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 15, 2002 Received: January 18, 2002

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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### Page 2 - Ms. Colleen Boswell

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,

Timothy A. Ulatowski

Timo Ky 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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# Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K020178 |

Device Name: belleGlass HP Modeling Gel

Indications For Use:

belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and
sculpting layers of composites and it is to be used between layers of cured composite.

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | K020178 |

(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)

{4}------------------------------------------------

## Section I

Indications for Use St.

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|----------------------------|
| 510(k) Number (if known): | K020178 |
| Device Name: | belleGlass HP Modeling Gel |

Indications For Use:

belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and
sculpting layers of composites and it is to be used between layers of cured composite.

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| ODA Number | K020178 |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.119)
(Optional Format 1-2)