TEMPOFIT, MODEL 02693

K994012 · Detax GmbH & Co. KG · EBG · Feb 16, 2000 · Dental

Device Facts

• Record ID: K994012
• Device Name: TEMPOFIT, MODEL 02693
• Applicant: Detax GmbH & Co. KG
• Product Code: EBG · Dental
• Decision Date: Feb 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1

Device Story

Tempofit is a self-curing, fast-setting bis-acrylic composite material used by dental professionals for the fabrication of temporary crowns and bridges. The device is supplied as a 2:1 ratio material. It functions as a restorative dental material to provide temporary coverage for prepared teeth. It is intended for clinical use by dentists.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing, fast-setting bis-acrylic composite material. Supplied in a 2:1 ratio. Class II dental device (Product Code: EBG).

Indications for Use

Indicated for the fabrication of temporary dental crowns and bridges.

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 eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2000

Dentax Gmbh & Company, KG c/o Mr. Barry Hale C.Q.E. Dentax Gmbh & Company, KG 7707 E 201 terr Belton, Missouri 64012

Re : K994012 Trade Name: Tempofit, Model 02693 Requlatory Class: II Product Code: EBG Dated: November 23, 2000 November 26, 2000 Received:

Dear Mr. Hale:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labelinq, 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 Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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

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Page 2 - Mr. Hale

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of obitgation you may the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in four tial equivalence of your device to a legally marketed predicate device results in a classification for your markets productorermits 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

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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## Statement of Indications for Use

510(k) Number(If known): K994012

Device Name: tempofit®

Indications For Use: Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1

> Please do not write below this line Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|-------------------------|--|
| Per 21 CFR 801.109 | |
| or Over-The-Counter Use | |
| Optional Format 1-2-96 | |

Susan Runne

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

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