CAVIT LC

K990982 · Espe Dental AG · EBF · Apr 23, 1999 · Dental

Device Facts

• Record ID: K990982
• Device Name: CAVIT LC
• Applicant: Espe Dental AG
• Product Code: EBF · Dental
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary fillings Temporary management of inlay and onlay preparations Temporary closure of implant screw holes Relining of temporary pre-made crowns and bridges

Device Story

CAVIT LC is a light-cured, tooth-shade resin material composed of methacrylates. It is used by dental professionals to restore carious lesions or structural tooth defects. The device serves as a temporary filling material, temporary management for inlay/onlay preparations, closure for implant screw holes, and for relining temporary crowns and bridges. It is a reformulation of a previous version (CAVIT-LC), with an updated monomer system designed to improve handling characteristics and reduce the rigidity of the uncured material. The material is applied by the clinician and cured via light activation to provide a temporary seal or restoration.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed no harmful potential; laboratory testing established effectiveness.

Technological Characteristics

Light-cured resin material composed of methacrylates. Formulated as a temporary filling material. Class II device (21 C.F.R. § 872.3690).

Indications for Use

Indicated for temporary dental restorations, including temporary fillings, management of inlay/onlay preparations, closure of implant screw holes, and relining of 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

• CAVIT-LC (old formula) (K972892)

Submission Summary (Full Text)

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4/23/99

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitter

II.

| Name: | ESPE Dental AG |
|------------------------------------|-------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Coce, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country | Germany |
| Establishment Registration Number: | 9611385 |
| Contact | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| E-mail | [e-mail] |
| Date: | March 22, 1999 |

#### Name of Dev ce

| Proprietary Name: | CAVIT® LC |
|----------------------|----------------------------------------|
| Classification Name: | Tooth shade resin material |
| Common Name: | Temporary light cured filling material |

### Predicate Device

CAVIT®-LC (old formula) by ESPE ....... K 972892

## Description for the Premarket Notification

CAVIT® LC is classified as a tooth shade resin material (21 C.F.R. § 872.3690) becaus it is a device composed of methacrylates intended to restore carious lesions o · structural defects in teeth.

CAVIT® LC is similar in intended use and substantially equivalent to ESPE's previously 510(k)-cleared temporary filling material CAVIT®-LC (old formula) which was never c n the market because it was determined by consultant dentists to have very insuffic ent material characteristics. The consultants complained about too high rigidity of the uncured material which made it almost impossible to fill it into the cavity.

Image /page/0/Picture/12 description: The image shows the text "510(k) Cavit ESPE". The text is arranged in a stacked format, with "510(k) Cavit" on top and "ESPE" below. There is a logo to the left of the text. The logo is a tree inside of a square.

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The now Cavin® LC is a further development based on the experience with the old CAVT -LC. The composition has changed, especially the monomer system was exchanced, which results in more advantageous material and handling characteristics.

To support the safety of the new formulation, biocompatibility testing was conducted which showed that CAVIT® LC has no harmful potential. The effectiveness is establis ned by laboratory testing.

Image /page/1/Picture/2 description: The image shows the text "510(k) CAVIT LC: ESPE:". The text is arranged in a vertical stack, with "510(k) CAVIT LC:" at the top and "ESPE:" at the bottom. There is a logo to the left of the text. The text is in a bold, sans-serif font.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany

Re: K990982 Trade Name: Cavit LC Regulatory Class: II Product Code: EBF March 22, 1999 Dated: March 24, 1999 Received:

#### Dear Dr. Petermann:

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 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). 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 (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 requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Petermann

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 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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamajn.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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K 990982

# STATEMENT OF INDICATIONS FOR USE

Device Name:

CAVIT® LC

Indications for use:

Temporary fillings

Temporary management of inlay and onlay preparations

Temporary closure of implant screw holes

Relining of temporary pre-made crowns and bridges

Susan Rumm

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

Prescription use: 区

Over-the counter use □