DENT-TEMP ACRYLIC

K972198 · Health-Dent Intl., Inc. · EBG · Dec 17, 1997 · Dental

Device Facts

• Record ID: K972198
• Device Name: DENT-TEMP ACRYLIC
• Applicant: Health-Dent Intl., Inc.
• Product Code: EBG · Dental
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer. DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used.

Device Story

Dent-Temp Acrylic is a self-curing polymer system used in restorative dentistry. It consists of a methacrylate polymer powder and a methylmethacrylate monomer liquid. The clinician mixes the components to create a material for fabricating temporary crown and bridge restorations. The material is designed to be durable, fast-setting, and easy to trim and polish. It is intended for professional use by dentists in a clinical setting to provide patients with temporary dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing methacrylate polymer powder and methylmethacrylate monomer liquid system. Available in three Vita-shades (A-1, A-2, A-3.5).

Indications for Use

Indicated for use in restorative dentistry for the fabrication of temporary crown and bridge restorations.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

Mr. Jashan Seth Executive Vice-President Health-Dent International, Incorporated 122-A Kirkland Circle Oswego, Illinois 60543

Re : K972198 Dent-Temp Acrylic Trade Name: Requlatory Class: II Product Code: EBG Dated: October 31, 1997 November 6, 1997 Received:

Dear Mr. Seth:

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 aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Seth

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 requlations.

This letter will allow you to beqin 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 diaqnostic 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 qeneral 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

My A. Ulatowski Timot 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

Mr. Jashan Seth Executive Vice-President Health-Dent International, Incorporated 122-A Kirkland Circle Oswego, Illinois 60543

Re : K972198 Dent-Temp Acrylic Trade Name: Requlatory Class: II Product Code: EBG Dated: October 31, 1997 November 6, 1997 Received:

Dear Mr. Seth:

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 aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

{3}------------------------------------------------

Page 2 - Mr. Seth

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 requlations.

This letter will allow you to beqin 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 diaqnostic 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 qeneral 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

My A. Ulatowski Timot 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 1 of 1

510 (k) Number (if known): K 972198

Device Name: DENT-TEMP™ ACRYLIC

Indications For Use:

DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer.

DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used.

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

| Susan Punno | | | | |
|---------------------------------------------------------------------|--------------------------|----|----------------------|----|
| (Division Sign-Off) | | | | |
| Division of Dental, Infection Control, and General Hospital Devices | | | | |
| 510(k) Number | R972198 | | | |
| Prescription Use | | OR | Over-The-Counter Use | No |
| (Per 21 CFR 801.109) | | | | |
| | (Optional Format 1-2-96) | | | |