AMELOGEN RESTORATIVE MATERIALS— 510(k) K932227

Name: FDA 510(k) clearance K932227
Creator: U.S. Food and Drug Administration
Published: 1993-09-13

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K932227 for AMELOGEN RESTORATIVE MATERIALS, Substantially Equivalent on 1993-09-13. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1993-05-07
Decision date: 1993-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, 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.