COLTENE RAPID— 510(k) K870047

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K870047 for COLTENE RAPID, Substantially Equivalent on 1987-01-29. 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: 1987-01-06
Decision date: 1987-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Coltene, Inc.

K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL1990-08-28
K882800 — COLTENE PRESIDENT JET REGULAR BODY1988-09-23
K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM1987-10-27
K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
K863998 — COLTENE JET-MIXER1986-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.