Clearance Summary
ELEMENTS OBTURATION UNIT received FDA 510(k) clearance under submission number K031664, sponsored by Sybron Endo/Analytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-04-28.
- Submission: K031664
- Applicant / Sponsor: Sybron Endo/Analytic
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2004-04-28
Classification & Regulation
This clearance is catalogued under FDA product code EKR and 21 CFR 872.4565, within the Dental review panel as a Class I device.