OSTEOGEN SBRG

Device Classification Name

bone grafting material, synthetic

510(k) Number K033098
Device Name OSTEOGEN SBRG
Applicant
IMPLADENT, LTD.
198-45 foothill ave.
holliswood, 
NY 
11423

Applicant Contact maurice valen
Correspondent
IMPLADENT, LTD.
198-45 foothill ave.
holliswood, 
NY 
11423

Correspodent Contact maurice valen
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 09/29/2003
Decision Date 04/27/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No