KETAC-MOLAR QUICK

K994251 · Espe Dental AG · EBF · Jan 3, 2000 · Dental

Device Facts

• Record ID: K994251
• Device Name: KETAC-MOLAR QUICK
• Applicant: Espe Dental AG
• Product Code: EBF · Dental
• Decision Date: Jan 3, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Linings for class I and II cavities filled with composite Core build-ups Fillings in deciduous teeth Fillings in class I cavities located in non- occlusal load bearing areas Fillings in class V cavities if the esthetics are not of primary importance Temporary fillings in class I and II cavities

Device Story

KETAC-MOLAR QUICK is a dental glass ionomer cement used for restorative procedures. It serves as a temporary filling, cavity lining, or core build-up material. The device is supplied in APLICAP capsules for clinical application. It functions via the same chemical design and operating principle as the predicate KETAC-MOLAR, but is modified to provide a shorter setting time. It is intended for use by dental professionals in a clinical setting. The material is placed into the tooth cavity to restore structure or protect the pulp. By providing a faster setting time, it improves clinical efficiency during restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Glass ionomer cement (other than zinc oxide-eugenol). Supplied in APLICAP capsules. Chemical composition identical to predicate KETAC-MOLAR. Modified for reduced setting time. Class II device per 21 C.F.R. § 872.3275(b).

Indications for Use

Indicated for patients requiring dental restorations, including linings for class I and II cavities, core build-ups, fillings in deciduous teeth, fillings in class I cavities in non-occlusal load-bearing areas, class V fillings where esthetics are secondary, and temporary fillings in class I and II cavities.

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

• KETAC®-MOLAR

Submission Summary (Full Text)

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#### IV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitter

| Company: | ESPE Dental AG |
|------------------------------------|-----------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Manager U.S.<br>Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail | [e-mail] |
| Date: | December 15 1999 |

## Name of Device

| Proprietary Name: | KETAC -MOLAR QUICK |
|-------------------|---------------------|
|-------------------|---------------------|

Classification Name: .........................................................................................................................................................

Common Name: .................................................................................................................................................................

## Predicate Device

KETAC®-MOLAR .................................................................................................................................................................

### Description for the Premarket Notification

KETAC®-MOLAR QUICK is a dental glass ionomer cement (other than zinc oxideeugenol) to serve e.g. as a temporary tooth filling and is classified according to 21 C.F.R. § 872.3275(b) as a class II device.

ESPE is submitting this Special 510(k) for modifications to its glass ionomer restorative cement KETAC®-MOLAR. The modified material is characterized by a

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shorter setting time. The material will be marketed under the name KETAC®-MOLAR Quick.

Like KETAC®-MOLAR, KETAC®-MOLAR QUICK is available in capsules tradenamed APLICAP®.

The modified glass ionomer cement KETAC®-MOLAR Quick has the following similarities to the unmodified KETAC®-MOLAR:

- KETAC®-MOLAR QUICK has the same intended use ●
- KETAC®-MOLAR QUICK is used by the same operating principle .
- KETAC®-MOLAR QUICK incorporates the same basic chemical design .
- . KETAC®-MOLAR QUICK has the same shelf life
- . KETAC®-MOLAR QUICK is manufactured and packaged using the same materials and processes

All chemical components of KETAC®-MOLAR QUICK are already part of the predicate device KETAC -MOLAR, are contained in other 510(k) cleared devices manufactured by ESPE, or are described in a pharmacopoeia. Therefore, we believe that additional biocompatibility testing is not required.

In summary the modified KETAC®-MOLAR QUICK described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.

Image /page/1/Picture/10 description: The image shows the text "Special 510(k) KETAC®-MOLAR QUICK" on the top line. Below that is the logo for ESPE. The logo is a stylized tree with the letters "ESPE" in bold font to the right of the tree.

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2000

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

Re: K994251 KETAC®-Molar Quick Trade Name: Regulatory Class: II Product Code: EBF Dated: December 15, 1999 Received: December 17, 1999

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 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 qeneral 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 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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#### Page 2 - Dr. Petermann

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 the Act for devices under 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 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 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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# STATEMENT OF INDICATIONS FOR USE

(As Required by 21 C.F.R. § 801.109)

510(k) Number:

K94251

Device Name:

KETAC®-MOLAR QUICK

Indications for use:

Linings for class I and II cavities filled with composite

Core build-ups

Fillings in deciduous teeth

Fillings in class I cavities located in non-

occlusal load bearing areas

Fillings in class V cavities if the esthetics are not of primary importance

Temporary fillings in class I and II cavities

Prescription use: 网

Over-the counter use □

(Division Sign-Off) familia bear for Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _699423