# K963735: Cojet System

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Nov 27, 1996 after 71 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902836 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902836: Microetcher, Danville Engineering, Inc. (1990) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K963735
Methodology: https://510kreport.com/methodology