MINERAL TRIOXIDE AGGREGATE (MTA)— 510(k) K964174

Name: FDA 510(k) clearance K964174
Creator: U.S. Food and Drug Administration
Published: 1997-02-10

Substantially Equivalent

Tulsa Dental Products, Ltd.

FDA 510(k) clearance K964174 for MINERAL TRIOXIDE AGGREGATE (MTA), Substantially Equivalent on 1997-02-10. Applicant: Tulsa Dental Products, Ltd.. Device class: 2.

Clearance details

Applicant: Tulsa Dental Products, Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1996-10-18
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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