510(k) K022224
K022224 is an FDA 510(k) premarket notification submitted by Coltene AG for the device "COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 18, 2002. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Coltene AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2002
- Date Received
- July 10, 2002
- 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