ALGINMAX, ORTHOCHROME— 510(k) K963205

Name: FDA 510(k) clearance K963205
Creator: U.S. Food and Drug Administration
Published: 1996-10-29

Substantially Equivalent

American Tooth Industries

FDA 510(k) clearance K963205 for ALGINMAX, ORTHOCHROME, Substantially Equivalent on 1996-10-29. Applicant: American Tooth Industries. Device class: 2.

Clearance details

Applicant: American Tooth Industries
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1996-08-09
Decision date: 1996-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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