AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE— 510(k) K973185

Name: FDA 510(k) clearance K973185
Creator: U.S. Food and Drug Administration
Published: 1997-11-14

Substantially Equivalent

American Dental Products, Inc.

FDA 510(k) clearance K973185 for AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE, Substantially Equivalent on 1997-11-14. Applicant: American Dental Products, Inc.. Device class: 2.

Clearance details

Applicant: American Dental Products, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1997-08-25
Decision date: 1997-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medinah, 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.