← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K960954

# KETAC-MOLAR APLICAP (K960954)

_Espe GmbH & Co. Kg. · EMA · May 16, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960954

## Device Facts

- **Applicant:** Espe GmbH & Co. Kg.
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** May 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Intended Use

Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: 1. linings for Class I and II cavities filled with composite; 2. core build-ups; 3. fillings in deciduous teeth; 4. fillings in Class I cavities located in non-occlusal load bearing areas; 5. fillings in Class V cavities if the aesthetics are not of primary importance; and 6. temporary fillings in Class I and II cavities.

## Device Story

Glass ionomer cement material; modification of Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap®; designed for improved compressive strength. Used by dental professionals in clinical settings for restorative procedures; provides structural support and filling material for various cavity classes and core build-ups. Applied via Aplicap® delivery system; hardens to provide dental restoration. Benefits include enhanced mechanical properties compared to predecessors while maintaining established glass ionomer clinical utility.

## Clinical Evidence

Bench testing only. Comparison of physical and technical characteristics and water-soluble fluoride content against predicate devices. Compliance with relevant DIN and ISO standards for dental cement confirmed.

## Technological Characteristics

Glass ionomer cement material; improved formulation for higher compressive strength. Meets relevant DIN and ISO standards for dental cement. Delivered via Aplicap® system.

## Regulatory 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

- Ketac-Bond® Aplicap® ([K874788](/device/K874788.md))
- Ketac-Silver® Aplicap® ([K843566](/device/K843566.md))

## Submission Summary (Full Text)

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K960954

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

ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for dental cement material, tradenamed Ketac-Bond® Aplicap® (K874788) and Ketac-Silver® Aplicap (K843566), to create slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar® Aplicap®. The reason for this modification is to provide for an improved compressive strength. Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses:

1. linings for Class I and II cavities filled with composite;
2. core build-ups;
3. fillings in deciduous teeth;
4. fillings in Class I cavities located in non-occlusal load bearing areas;
5. fillings in Class V cavities if the aesthetics are not of primary importance; and
6. temporary fillings in Class I and II cavities.

ESPE is claiming substantial equivalence to its previously cleared Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap® products. These products have similar intended uses and, in the case of Ketac-Bond® Aplicap®, the same principal ingredient composition.

To support substantial equivalence to predicate products, the physical and technical characteristics, as well as the water soluble fluoride content, of Ketac-Molar® Aplicap® have been compared to those of Ketac-Bond® Aplicap® and Ketac-Silver®.

W401A/A31059.1
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Aplicap®. Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.

ESPE's 510(k) has been submitted on March 6, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

WADIA/A21059.1
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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960954](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960954)

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