PEAK BOND, MODEL 5133— 510(k) K063557

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K063557 for PEAK BOND, MODEL 5133, Substantially Equivalent on 2006-12-12. 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: 2006-11-27
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Special
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.