Clearance Summary
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM received FDA 510(k) clearance under submission number K051660, sponsored by Coltene/Whaledent, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-08-04.
- Submission: K051660
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6870
- Decision date: 2005-08-04
Classification & Regulation
This clearance is catalogued under FDA product code KMH and 21 CFR 880.6870, within the General Hospital review panel as a Class II device.