COLTENE COLTEX/COLTOFLAX— 510(k) K811666

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K811666 for COLTENE COLTEX/COLTOFLAX, Substantially Equivalent on 1981-07-15. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1981-06-15
Decision date: 1981-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Coltene, Inc.

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K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
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Data sourced from openFDA. This site is unofficial and independent of the FDA.