SAPPHIRE PLASMA ARC DENTAL CURING LIGHT— 510(k) K081287

Name: FDA 510(k) clearance K081287
Creator: U.S. Food and Drug Administration
Published: 2008-11-21

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K081287 for SAPPHIRE PLASMA ARC DENTAL CURING LIGHT, Substantially Equivalent on 2008-11-21. Applicant: Den-Mat Holdings, LLC. Device class: 2.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2008-05-07
Decision date: 2008-11-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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