BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD


Device Classification Name

bone grafting material, synthetic

510(k) Number K080308
Device Name BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
Applicant
BIOSCAFFOLD INTERNATIONAL PTE LTD
piazza albania, 10
rome, 

IT

00153

Applicant Contact roger gray
Correspondent
BIOSCAFFOLD INTERNATIONAL PTE LTD
piazza albania, 10
rome, 

IT

00153

Correspodent Contact roger gray
Regulation Number 872.3930
Classification Product Code
LYC  
Subsequent Product Code
NPK  
Date Received 02/05/2008
Decision Date 04/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No