B-SYSTEM SILICONE

K982917 · Sybron Dental Specialties, Inc. · ELW · Oct 16, 1998 · Dental

Device Facts

• Record ID: K982917
• Device Name: B-SYSTEM SILICONE
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

Device Story

B-System Silicone is a condensation-cured elastomeric impression material. Used by dental professionals in clinical settings to create accurate molds of oral structures. The material is applied to the patient's dental arch to capture the geometry of teeth and gums for the fabrication of full dentures, partial dentures, inlays, onlays, crowns, and bridges. The resulting impression serves as a physical template for dental laboratory procedures. The device facilitates the creation of custom-fitted dental prosthetics, aiding in restorative and rehabilitative dental care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Condensation-cured silicone elastomeric impression material. Classified as an impression material under 21 CFR § 872.3660. Product code ELW. Regulatory Class II.

Indications for Use

Indicated for dental impressions for patients requiring full dentures, partial dentures, inlays, onlays, crowns, and bridges.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Heraeus Kulzer, Inc., CutterSil® Polysiloxane Impression Materials

Submission Summary (Full Text)

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OCT 6 1998

# SYBRON DENTAL SPECIA

# 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: August 1998

## Device Name:

- Trade Name B-System Silicone .
- Common Name Silicone Impression Material .
- Classification Name Impression Material, per 21 CFR § 872.3660 .

## Devices for Which Substantial Equivalence is Claimed:

- Heraeus Kulzer, Inc., CutterSil® Polysiloxane Impression Materials .
#### Device Description:

The device is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

#### Intended Use of the Device:

The intended use of B-System Silicone is for dental impressions of full dentures, partial dentures, inlays, onlays, crowns and bridges.

#### Substantial Equivalence:

B-System Silicone is substantially equivalent to several other legally marketed devices in the United States. The condensation cured elastomeric impression material marketed by Heraeus Kulzer, Inc. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1998

Ms. Colleen Boswell Senior Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re : K982917 B-System Silicone Trade Name: Regulatory Class: II Product Code: ELW Dated: August 18, 1998 Received: August 19, 1998

Dear Ms. Boswell:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any 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.

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Page 2 - Ms. Boswell

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" (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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Section I - Indications for Use

510(k) Number:

K982917

Device Name:

B-System Silicone

Indications for Use:

B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

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

510(k) Number