OTA COLLAGEN BIOMATERIAL


Device Classification Name

barrier, animal source, intraoral

510(k) Number K073685
Device Name OTA COLLAGEN BIOMATERIAL
Applicant
OSSEOUS TECHNOLOGIES OF AMERICA
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact david j collette
Correspondent
OSSEOUS TECHNOLOGIES OF AMERICA
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact david j collette
Regulation Number 872.3930
Classification Product Code
NPL  
Date Received 12/28/2007
Decision Date 08/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No