510(k) K181965
K181965 is an FDA 510(k) premarket notification submitted by Dr. Collins, Inc. for the device "Restore Toothpaste". The FDA issued a decision of Substantially Equivalent on June 13, 2019. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Dr. Collins, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2019
- Date Received
- July 23, 2018
- 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