COLTENE ORALLOY MAGICAPS— 510(k) K840297

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K840297 for COLTENE ORALLOY MAGICAPS, Substantially Equivalent on 1984-03-16. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1984-01-24
Decision date: 1984-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Coltene, Inc.

K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL1990-08-28
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K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM1987-10-27
K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
K870047 — COLTENE RAPID1987-01-29

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