510(k) K942742

ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV by Wallace A. Erickson & Co. — Product Code DYH

K942742 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Wallace A. Erickson & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1994
Date Received
June 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type