SAPPHIRE PLASMA ARC DENTAL CURING LIGHT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K081287
Device Name SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
Applicant
DEN-MAT HOLDINGS, LLC
2727 skyway dr.
santa maria, 
CA 
93455

Applicant Contact alan matthews
Correspondent
DEN-MAT HOLDINGS, LLC
2727 skyway dr.
santa maria, 
CA 
93455

Correspodent Contact alan matthews
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 05/07/2008
Decision Date 11/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No