← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K962428

# EBS (ESPE BONDING SYSTEM) (K962428)

_Espe GmbH & Co. Kg. · KLE · Sep 12, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962428

## Device Facts

- **Applicant:** Espe GmbH & Co. Kg.
- **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md)
- **Decision Date:** Sep 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3200
- **Device Class:** Class 2
- **Review Panel:** Dental

## Intended Use

The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

## Device Story

3-component resin tooth bonding system; includes etching gel, primer, and bonding agent. Used by dentists to facilitate adhesion of composite materials to tooth structure. System components are applied sequentially to prepare tooth surface for composite restoration. Benefits include improved retention of dental composites.

## Clinical Evidence

Bench testing only; shear bond strength comparison performed between EBS® System and 3M Scotchbond™ Multi-Purpose Dental Adhesive System.

## Technological Characteristics

3-component dental adhesive system consisting of etching gel, primer, and bonding agent. Chemical composition identical to predicate primer.

## Regulatory Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

## Predicate Devices

- 3M's Scotchbond™ Multi-Purpose Dental Adhesive System ([K920424](/device/K920424.md))

## Reference Devices

- ESPE MiniTip Etching Gel ([K810266](/device/K810266.md))
- ESPE Pertac® Universal Bond ([K904289](/device/K904289.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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SEP 12 1996 K962428

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

ESPE is submitting a 510(k) premarket notification for its 3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent. The etching gel used in the EBS® System is ESPE's 510(k) cleared MiniTip Etching Gel (K810266), and the bonding agent used in the EBS® product is ESPE's 510(k) cleared Pertac® Universal Bond (K904289), tradenamed EBS® Bond. The primer used in the EBS® product, tradenamed EBS® Primer, is substantially equivalent to the primer in 3M's Scotchbond™ Multi-Purpose Dental Adhesive System (K920424). Both products have identical ingredient compositions and the same intended uses.

To support substantial equivalence to 3M's predicate product, the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System.

ESPE's 510(k) has been submitted on June 24, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

W401A/A40418.1

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962428](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K962428)

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