OPALDAM— 510(k) K971284

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K971284 for OPALDAM, Substantially Equivalent on 1997-06-03. Applicant: Ultradent Products, Inc..

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EIG
Advisory panel: Dental
Date received: 1997-04-07
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.