510(k) K100606
K100606 is an FDA 510(k) premarket notification submitted by Redent Nova, Ltd. for the device "VATEA ENDONTIC IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 2010. The device falls under product code NYL (Handpiece, Air-Powered, Root Canal Irrigation), a Class I device regulated under 21 CFR 872.4200. Redent Nova, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2010
- Date Received
- March 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Root Canal Irrigation
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
To clean the root canal prior to filling and used for root canal irrigation.