CAVIT-LC

K972892 · Espe GmbH & Co. Kg. · EBF · Oct 2, 1997 · Dental

Device Facts

• Record ID: K972892
• Device Name: CAVIT-LC
• Applicant: Espe GmbH & Co. Kg.
• Product Code: EBF · Dental
• Decision Date: Oct 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary fillings for inlay and onlay preparations. Temporary fillings in cavities; temporary fillings of implant sites; and relining of prefabricated temporary crowns and bridges.

Device Story

Cavit-LC is a light-curing temporary filling material used by dental professionals in clinical settings. The material is applied to dental preparations or implant sites and cured using a dental light source to provide a temporary seal. It serves as a restorative material for inlay/onlay preparations, cavities, implant sites, and for relining prefabricated temporary crowns and bridges. The device benefits patients by providing a temporary, protective barrier during the interim period between dental procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility studies (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization) and physical/technical characteristic comparisons to predicate devices.

Technological Characteristics

Light-curing resin-based temporary filling material. Formulated as a paste for manual application. Cured via external dental light source. Biocompatibility verified through standard toxicological testing.

Indications for Use

Indicated for temporary dental restorations including inlay/onlay preparations, cavity fillings, implant site fillings, and relining of prefabricated temporary crowns and bridges.

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

• Fermit-N Light-Curing Temporary Filling Material (K934978)
• Clip (K926418)

Submission Summary (Full Text)

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K972892

## II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

ESPE is submitting a 510(k) premarket notification for tooth shade resin material, tradenamed Cavit®-LC. Cavit®-LC is a light-curing temporary filling material indicated for the following uses: (1) temporary fillings for inlay and onlay preparations; (2) temporary fillings in cavities; (3) temporary fillings of implant sites; and (4) relining of prefabricated temporary crowns and bridges.

ESPE is claiming substantial equivalence to the previously cleared temporary filling materials Fermit-N Light-Curing Temporary Filling Material (K934978) and Clip® (K926418). Cavit®LC, Fermit-N, and Clip® have similar intended uses and Cavit®-LC and Fermit-N have similar principal ingredient composition. To support substantial equivalence to predicate products, the physical and technical characteristics of Cavit™-LC have been compared to those of Fermit-N and Clip. 8 In addition, certain tests have been undertaken on the final Cavit®-LC product, including cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization.

ESPE's 510(k) has been submitted on August 4, 1997, by Dr. Barbara Wagner-Schuh at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 2 1997

Dr. Barbara Wagner-Schuh Regulatory Affairs ESPE GMBH & Company KG AM Griesberg 2 Seefeld, OBB Germany

K972892 Re : Cavit-LC Trade Name: Regulatory Class: II Product Code: EBF Dated: August 4, 1997 Received: Auqust 5, 1997

## Dear Dr. Waqner-Schuh:

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, 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. ಗಳ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Wagner-Schuh

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 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.qov/cdrh/dsmamain.html".

Sincerely Yours,

Timo ühv 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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## STATEMENT OF INDICATIONS FOR USE

Device Name: Cavit®-LC

Indications for use:

- Temporary fillings for inlay and onlay preparations .
- Temporary fillings of cavities ●
- Temporary filling of implant sites ●
- Relining of prefabricated temporary crowns and bridges .

Sueen Ruarrez

(Division Sign-Off) Division of Dental, Infection Control. Didision of Dental, Info
and General Hospital Deneral Deneral Deneral
510(k) Number 510(k) Number .

Prescription Use X_ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________