KETAC-FIL APLICAP PLUS

K973262 · Espe GmbH & Co. Kg. · EMA · Nov 17, 1997 · Dental

Device Facts

• Record ID: K973262
• Device Name: KETAC-FIL APLICAP PLUS
• Applicant: Espe GmbH & Co. Kg.
• Product Code: EMA · Dental
• Decision Date: Nov 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ketac-Fi10 Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.

Device Story

Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material used by dental professionals for restorative procedures. The device consists of a powder and liquid component, modified from previous versions to include new pigments for improved translucency and aesthetics. It is applied by clinicians in a dental office setting to fill cavities, seal fissures, and perform core build-ups. The material functions as a dental cement to provide structural support and aesthetic restoration for teeth. The output is a hardened dental material that aids in tooth repair and preservation.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted including cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity. Device meets relevant DIN and ISO standards for dental cement.

Technological Characteristics

Glass ionomer cement material. Modified silicate glass and pigments. Meets DIN and ISO standards for dental cement. Supplied in Aplicap® delivery system.

Indications for Use

Indicated for patients requiring dental restorations including Black Class III and V cavities, wedge-shaped defects, fissure sealing, small Black Class I cavities, deciduous teeth restorations, and core build-ups.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Photac-Fil® Aplicap® (K925027)
• Ketac-Molar® Aplicap® (K960954)

Submission Summary (Full Text)

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KA73262

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

ESPE is submitting a 510(k) premarket notification for its modified glass ionomer cement material, Ketac-Fil® Aplicap® Plus. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments. The reason for this modification is to provide the user of conventional glass ionomer cement products with additional cement shade options of better translucency and improved aesthetics. Ketac-Fi10 Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.

ESPE is claiming substantial equivalence to its previously cleared Photac-Fil® Aplicap® and Ketac-Molar® Aplicap® products. Ketac-Fil® Aplicap® Plus and Photac-Fil® Aplicap® have substantially similar intended uses, and the ingredients of the powder portion of the products are similar, except for a slightly modified silicate glass, and the addition of two new pigments. Ketac-Fil® Aplicap® Plus and Ketac-Molar® Aplicap® have similar intended uses, and the liquid portion of the products are identical.

To support substantial equivalence to predicate products, the physical and technical characteristics of Ketac-Fil® Aplicap® Plus have been compared to those of Photac-Fil® Aplicap® and Ketac-Molar® Aplicap® In addition, certain tests have been conducted on Ketac-Fil®

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Aplicap® Plus to confirm safe use of the modified silicate glass and new pigments used. Cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity tests have been conducted, and results are provided.

Ketac-Fil® Aplicap® Plus meets the requirements of relevant DIN and ISO standards for dental cement.

ESPE's 510(k) has been submitted on August 29, 1997 by Dr. Barbara Wagner-Schuh, at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 17 1997

Re : K973262 Ketac-Fil® Aplicap® Plus Trade Name: Requlatory Class: II Product Code: EMA Dated: November 7, 1997 Received: November 12, 1997

Dear Dr. Wagner-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 reqistration, listing of devices, qood 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. ದ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Dr. Wagner-Schuh

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 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 requlation (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 K973262

OR

Device Name: Ketac-Fil® Aplicap® Plus

## Indications for use:

- Fillings of Black Classes III and V cavities ●
- Wedge-shaped defects ●
- Fissure sealing �

:

- Small Black Class I cavities .
- . Deciduous teeth
- & Core build-ups

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Prescription Use **X**

(Division Sign-Off)
Division of Dental Infection Control.

Division of Dental, Infection Control, and General Hospital Devi 510(k) Number

Over-The-Counter Use No