510(k) K250015
K250015 is an FDA 510(k) premarket notification submitted by Ormco Corporation for the device "Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Ormco Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2025
- Date Received
- January 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device Class
- Class II
- Regulation Number
- 872.3750
- Review Panel
- DE
- Submission Type