DERMADAM— 510(k) K964810

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K964810 for DERMADAM, Substantially Equivalent on 1997-02-10. Applicant: Ultradent Products, Inc.. Device class: 1.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EFS
Device class: Class 1
Regulation: 21 CFR 872.6510
Advisory panel: Dental
Date received: 1996-11-29
Decision date: 1997-02-10
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.