← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K963737

# HYCEM APLICAP (K963737)

_Espe GmbH & Co. Kg. · EMA · Nov 15, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963737

## Device Facts

- **Applicant:** Espe GmbH & Co. Kg.
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** Nov 15, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

## Device Story

Hycem® Aplicap® is a compomer luting cement; used for final cementation of dental restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands). Applied by dental professionals in clinical settings. Provides adhesive fixation of prosthetic components to tooth structure. Benefits include secure retention of dental restorations.

## Clinical Evidence

Bench testing only; compliance with DIN and ISO standards for dental cement demonstrated.

## Technological Characteristics

Compomer luting cement; composition and physical properties verified against DIN and ISO standards for dental materials.

## 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

- Advance™ Hybrid Ionomer Cement (Dentsply Caulk)

## Submission Summary (Full Text)

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NOV 15 1996
K963737

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

ESPE is submitting a 510(k) premarket notification for its compomer luting cement, tradenamed Hycem® Aplicap®. Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

ESPE is claiming substantial equivalence to Dentsply Caulk’s Advance™ Hybrid Ionomer Cement. These products have the same intended use and similar composition.

To support the substantial equivalence to predicate products, the composition and the physical and technical characteristics of Hycem® Aplicap® have been compared to those of Advance™ Hybrid Ionomer Cement. Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.

ESPE’s 510(k) has been submitted on September 17, 1996 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

401A/6473S.1

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963737](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963737)

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