ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)

Device Classification Name

agent, tooth bonding, resin

510(k) Number K960365
Device Name ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
Applicant
WALLACE A. ERICKSON & CO.
1920 north clybourn ave.
chicago, 
IL 
60614

Applicant Contact abner t de la cruz
Correspondent
WALLACE A. ERICKSON & CO.
1920 north clybourn ave.
chicago, 
IL 
60614

Correspodent Contact abner t de la cruz
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 01/25/1996
Decision Date 03/28/1996
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Dental

510k Review Panel

Dental
Type Traditional
Reviewed by Third Party No
Combination Product

No