# Coltene, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 15 (1981–2004): 15 510(k) clearances
- Names in FDA's records: Coltene, Inc. (13); Coltene AG (2)
- Product codes: ELW (6), EJJ (2), EBF (2), EBG (1), EMA (1), EID (1), EKS (1), DYH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Coltene/Whaledent, Inc.: 1 (https://510kreport.com/company/coltene-whaledent)

## Its most-cited devices
- K811767: Coltene President Impression Materials (1981), cited by 1

## Recent decisions
- K041098: Cool Temp Natural (May 13, 2004)
- K022224: Cool Bond Light Cured Bracket Adhesive System (Sep 18, 2002)
- K902392: Coltosol Temporary Endodontic Filling Material (Aug 28, 1990)
- K882800: Coltene President Jet Regular Body (Sep 23, 1988)
- K873671: Coltene President Jet Impression Materials System (Oct 27, 1987)
- K870266: Coltene Brilliant D.I. Direct Inlay System (Feb 27, 1987)
- K870047: Coltene Rapid (Jan 29, 1987)
- K863998: Coltene Jet-Mixer (Oct 30, 1986)

Source page: https://510kreport.com/company/coltene