RM BOND, MODEL J032


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K072830
Device Name RM BOND, MODEL J032
Applicant
PENTRON CLINICAL TECHNOLOGIES
68-70 north plains industrial
road
wallingford, 
CT 
06492

Applicant Contact greg moreau
Correspondent
PENTRON CLINICAL TECHNOLOGIES
68-70 north plains industrial
road
wallingford, 
CT 
06492

Correspodent Contact greg moreau
Regulation Number 872.3750
Classification Product Code
DYH  
Subsequent Product Code
EBF  
Date Received 10/03/2007
Decision Date 12/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No