Clearance Summary
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II received FDA 510(k) clearance under submission number K093221, sponsored by Dentsply Intl., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-10-30.
- Submission: K093221
- Applicant / Sponsor: Dentsply Intl., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3750
- Decision date: 2009-10-30
Classification & Regulation
This clearance is catalogued under FDA product code DYH and 21 CFR 872.3750, within the Dental review panel as a Class II device.