HYTAC

K992909 · Espe Dental AG · EBF · Nov 24, 1999 · Dental

Device Facts

• Record ID: K992909
• Device Name: HYTAC
• Applicant: Espe Dental AG
• Product Code: EBF · Dental
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings

Device Story

HYTAC® is a compomer filling material composed of methacrylates used by dentists to restore carious lesions or structural defects in teeth. It is applied directly to the tooth cavity to fill Class I, III, V, and semipermanent Class II defects. The material functions as a restorative resin. It is used in a clinical dental setting by a licensed practitioner. The device benefits patients by providing a durable material for tooth restoration, including occlusal loaded areas, following the removal of the previous contraindication for such use.

Clinical Evidence

Clinical evidence includes laboratory test data and a comparative study against the predicate device, Dyract® AP. No new chemical or toxicological data was provided as the composition remains unchanged. The evidence supports the expansion of indications to include occlusal loaded fillings and permanent Class I and semipermanent Class II fillings.

Technological Characteristics

Compomer filling material composed of methacrylates. Classified as a tooth shade resin material (21 C.F.R. § 872.3690).

Indications for Use

Indicated for patients requiring restoration of carious lesions or structural defects in teeth, specifically primary tooth fillings, Class I, III, and V fillings, wedge-shaped defects, and Class II semipermanent fillings (defined as up to two years).

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

• Dyract® AP by DENTSPLY

Submission Summary (Full Text)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter

II.

| Name: | 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 of U.S.<br>Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | August 27, 1999 |
| Name of Device | |
| Proprietary Name: | HYTAC® |
| Classification Name: | Tooth shade resin material |
| Common Name: | Compomer filling material |
| Predicate Device | |

HYTAC® by ESPE................................................................................................................................................................

Dyract® AP by DENTSPLY........................................................................................................................................................

Description for the Premarket Notification

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

Image /page/0/Picture/8 description: The image shows the text "510(k) HyTAC®" above the word "ESPE". To the left of the word ESPE is a logo that appears to be a tree. The registered trademark symbol is located to the right of the word HyTAC.

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On September 11, 1996 HYTAC® was 510(k)-cleared by the FDA. Because at that time no further clinical evidence was available, the range of indications was strictly limited to none-occlusal loaded fillings. Therefore, the information for use contained a contraindication phrase "HYTAC® is not indicated […] for long-term fillings in the permanent dentition exposed to occlusal loading".

However, good clinical experience, laboratory test data and comparison to DYRACT® AP by a study make it now possible in our point of view to expand the range of indications to occlusal loaded fillings, too. The above mentioned contraindication phrase will therefore be deleted in the Instructions for Use. The range of indications for HYTAC® will be expanded on permanent class I fillings and semipermanent class II fillings. The phrase "semipermanent" has to be understood as a period of up to two years.

Due to the 510(k) Memorandum #K97-1, released on January 10, 1997, "Deciding when to submit a 510(k) for a change to an existing device", deletion of a contraindication on one hand and expanding the range of indications on the other hand requires the submission of a new 510(k).

While the composition of HYTAC® remains still the same, in this 510(k) submission only the differences to the old submission are cited. Therefore, no chemical and toxicological data is contained to reduce unnecessary paperwork.

Image /page/1/Picture/4 description: The image shows the logo for 510(k) HYTAC ESPE. The logo is black and white and features the text "510(k) HYTAC" in a smaller font above the text "ESPE" in a larger font. There is a registered trademark symbol next to HYTAC. To the left of ESPE is a logo of a 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

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

K992909 Re : Hytac® Trade Name: Regulatory Class: II Product Code: EBF August 27, 1999 Dated: Received: August 30, 1999

Dear Dr. Andreas 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, 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 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 Regulations, 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Dr. Petermann

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 asboing 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 regulation entitled, "Misbranding by reference to ene rogaracion charion" (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

Directbr 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:

Device Name:

HYTAC®

Indications for use:

Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings

Prescription use: 17

Susan Runo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devise Of Of 510(k) Number .

Over-the counter use □