SAPPHIRE O/E ORAL EXAMINATION SYSTEM


Device Classification Name

diagnostic light, soft tissue detector

510(k) Number K073483
Device Name SAPPHIRE O/E ORAL EXAMINATION SYSTEM
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 872.6350
Classification Product Code
NXV  
Date Received 12/11/2007
Decision Date 04/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No