510(k) K102973
K102973 is an FDA 510(k) premarket notification submitted by Cooley Consulting, Inc. for the device "SILVER DENTAL ARREST". The FDA issued a decision of Substantially Equivalent on July 31, 2014. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2014
- Date Received
- October 6, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.