REPROBONE DENTAL GRAFTING MATERIAL


Device Classification Name

bone grafting material, synthetic

510(k) Number K103820
Device Name REPROBONE DENTAL GRAFTING MATERIAL
Applicant
CERAMISYS LTD
344 annabelle point road
centerville, 
MA 
02632 -2402

Applicant Contact hillard w welch
Correspondent
CERAMISYS LTD
344 annabelle point road
centerville, 
MA 
02632 -2402

Correspodent Contact hillard w welch
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 12/30/2010
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No