SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE


Device Classification Name

material, tooth shade, resin

510(k) Number K030133
Device Name SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
Original Applicant
DENTALEZ GROUP
1816 colonial village ln.
lancaster, 
PA 
17601

Original Contact william guscott
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 01/14/2003
Decision Date 04/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No