DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD— 510(k) K935152

Name: FDA 510(k) clearance K935152
Creator: U.S. Food and Drug Administration
Published: 1994-01-31

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K935152 for DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD, Substantially Equivalent on 1994-01-31. Applicant: Dentauraum, Inc.. Device class: 1.

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code DYO
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-10-28
Decision date: 1994-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

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