GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER— 510(k) K933360

Name: FDA 510(k) clearance K933360
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Miles Inc., Dental Products

FDA 510(k) clearance K933360 for GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER, Substantially Equivalent on 1994-11-22. Applicant: Miles Inc., Dental Products. Device class: 2.

Clearance details

Applicant: Miles Inc., Dental Products
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1993-07-09
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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