Clearance Summary
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 received FDA 510(k) clearance under submission number K071106, sponsored by Ultradent Products, 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 2007-05-08.
- Submission: K071106
- Applicant / Sponsor: Ultradent Products, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2007-05-08
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.