HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI— 510(k) K852766

Name: FDA 510(k) clearance K852766
Creator: U.S. Food and Drug Administration
Published: 1985-10-21

Substantially Equivalent

Orthomatrix, Inc.

FDA 510(k) clearance K852766 for HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI, Substantially Equivalent on 1985-10-21. Applicant: Orthomatrix, Inc.. Device class: 2.

Clearance details

Applicant: Orthomatrix, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1985-06-28
Decision date: 1985-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

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