PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)— 510(k) K100752

Name: FDA 510(k) clearance K100752
Creator: U.S. Food and Drug Administration
Published: 2010-07-16

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K100752 for PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE), Substantially Equivalent on 2010-07-16. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2010-03-17
Decision date: 2010-07-16
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.