510(k) K921044
K921044 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND". The FDA issued a decision of Substantially Equivalent on Nov 9, 1992. 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
- Nov 9, 1992
- Date Received
- Mar 4, 1992
- 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)