AONGEN DENTAL COLLAGEN MATRIX


Device Classification Name

dressing, wound and burn, hydrogel w/drug and/or biologic

510(k) Number K112568
Device Name AONGEN DENTAL COLLAGEN MATRIX
Applicant
AEON ASTRON EUROPE B.V.
niels bohrweg 11-13
leiden, 

NL

2333 ca

Applicant Contact horng ji lai
Correspondent
AEON ASTRON EUROPE B.V.
niels bohrweg 11-13
leiden, 

NL

2333 ca

Correspodent Contact horng ji lai
Classification Product Code
MGQ  
Date Received 09/06/2011
Decision Date 03/01/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No