B1P ADHESIVE


Device Classification Name

agent, tooth bonding, resin

510(k) Number K111431
Device Name B1P ADHESIVE
Applicant
PENTRON CLINICAL
1717 west collins avenue
orange, 
CA 
92867

Applicant Contact wendy garman
Correspondent
PENTRON CLINICAL
1717 west collins avenue
orange, 
CA 
92867

Correspodent Contact wendy garman
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 05/23/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No