510(k) K935625
K935625 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on Aug 10, 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 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 1994
- Date Received
- Nov 22, 1993
- 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
- 510(k)