← Product Code [EBF](/productcode/EBF) · K963735

# COJET SYSTEM (K963735)

_Espe GmbH & Co. Kg. · EBF · Nov 27, 1996 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K963735

## Device Facts

- **Applicant:** Espe GmbH & Co. Kg.
- **Product Code:** [EBF](/productcode/EBF.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3690
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

adhesive repair of defects in porcelain adhesive repair of defects in porcelain with exposed metal adhesive repair of defects in composite adhesive repair of defects in composite with exposed metal conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc. conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.

## Device Story

CoJet™-System is a 4-component dental kit for intraoral adhesive repair and cementation pretreatment. System utilizes CoJet™-Sand (30 µm aluminum oxide with iron oxide pigment) for surface abrasion, silane coupling agent (ESPE®-SIL), bonding material (Visio®-Bond), and opaquer. Used by dentists in clinical settings to prepare surfaces of crowns, bridges, inlays, onlays, root posts, and veneers. Operates via mechanical abrasion of restoration surfaces to enhance adhesion; components previously cleared for extraoral use now validated for intraoral application. Benefits include improved bond strength for intraoral restoration repairs and cementation, reducing need for restoration replacement.

## Clinical Evidence

Bench testing only. Performance data demonstrates that product performance is not affected by intraoral preparation and use compared to extraoral preparation.

## Technological Characteristics

4-component system: 30 µm aluminum oxide abrasive (with iron oxide pigment C.I. 77491), silane coupling agent, bonding resin, and light-polymerized opaquer. Mechanical abrasion principle. Components are chemically identical to previously cleared ESPE materials.

## Regulatory 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

- Rocatec®-Plus ([K913857](/device/K913857.md))
- Microetcher™ Dental Bonding System ([K902836](/device/K902836.md)/A)
- ESPE®-SIL ([K913965](/device/K913965.md))
- Visio®-Bond ([K790833](/device/K790833.md)/B)
- Visio®-Gem ([K833757](/device/K833757.md))

## Reference Devices

- Photac®-Fil Aplicap® ([K925027](/device/K925027.md))
- Dimension materials ([K960547](/device/K960547.md))
- Pertac®-Hybrid ([K900510](/device/K900510.md))
- Sono-Cem ([K913966](/device/K913966.md))
- Ketac-Endo Aplicap® ([K911061](/device/K911061.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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K963735

NOV 27 1996

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

ESPE is submitting a 510(k) premarket notification for its 4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The CoJet™-System’s intraoral adhesive restoration repair and adhesive cementation uses include:

- adhesive repair of defects in porcelain
- adhesive repair of defects in porcelain with exposed metal
- adhesive repair of defects in composite
- adhesive repair of defects in composite with exposed metal
- conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
- conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.

The CoJet™-Sand used in the CoJet™-System is ESPE’s 510(k)-cleared Rocatec®-Plus (K913857), except for the addition of a pigment, iron oxide (C.I. 77491), and the use of more finely grained sand (30 $\mu$m versus 110 $\mu$m). The iron oxide pigment is a medical device-listed color additive at 21 C.F.R. § 73.3125, and has been used in the following ESPE 510(k)-cleared products: Photac®-Fil Aplicap® (K925027), Dimension materials (K960547), Pertac®-Hybrid (K900510), Sono-Cem (K913966), and Ketac-Endo Aplicap® (K911061). CoJet™-Sand also is

VAS1A/65040.1

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substantially equivalent to the aluminum oxide material used in the Microetcher™ Dental Bonding System (K902836/A). The silane coupling agent in the System is ESPE’s 510(k)-cleared ESPE®-SIL (K913965), and the bonding material is ESPE’s 510(k)-cleared Visio®-Bond (K790833/B). Finally, the Opaquer is a component of Visio®-Gem, ESPE’s 510(k)-cleared crown and bridge veneer material for light polymerization (K833757). The only modification to these previously cleared ESPE components is that they will be prepared and used intraorally, rather than prepared extraorally, for subsequent intraoral use. One of the predicates for CoJet™-Sand, Microetcher™, however, has been cleared for intraoral preparation and use. Performance data demonstrate that the products’ performance is not affected by intraoral preparation and use.

ESPE’s 510(k) has been submitted on September 17, 1995 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).

W401A/65040.1

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**Source:** [https://fda-staging.innolitics.com/device/K963735](https://fda-staging.innolitics.com/device/K963735)

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