GI DENTSTAT— 510(k) K060334

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K060334 for GI DENTSTAT, Substantially Equivalent on 2006-02-23. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2006-02-09
Decision date: 2006-02-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.