510(k) K061359
K061359 is an FDA 510(k) premarket notification submitted by Novamin Technology, Inc. for the device "DENSHIELD TREATMENT FOR SENSITIVE TEETH". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Novamin Technology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2006
- Date Received
- May 16, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type