3M UNITEK LAVA CHAIRSIDE ORAL SCANNER— 510(k) K081961

Name: FDA 510(k) clearance K081961
Creator: U.S. Food and Drug Administration
Published: 2008-09-05

Substantially Equivalent

Brontes Technologies

FDA 510(k) clearance K081961 for 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER, Substantially Equivalent on 2008-09-05. Applicant: Brontes Technologies. Device class: 2.

Clearance details

Applicant: Brontes Technologies
Product code: Code NOF
Device class: Class 2
Regulation: 21 CFR 872.3661
Advisory panel: Dental
Date received: 2008-07-09
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, 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.