Diammine Silver Fluoride Dental Hypersensitivity Varnish
The Diammine Silver Fluoride Dental Hypersensitivity Varnish is a dental device applied to tooth enamel to block dentinal tubules and reduce tooth sensitivity. It is an FDA Class 2 device regulated under 21 CFR 872.3260, requiring 510(k) premarket notification, within the Dental (DE) medical specialty. The product code is PHR, and it is eligible for third-party review. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PHR
- Device Class
- FDA class 2
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250222 | SDF Pro | May 07, 2025 | Substantially Equivalent | Belport Company, Inc., Gingi-Pak |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Feb 28, 2025 | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC |
| K240059 | FAgamin® | May 16, 2024 | Substantially Equivalent | Tedequim Srl |
| K240619 | e-SDF | Mar 06, 2024 | Substantially Equivalent | Kids-E-Dental Llp |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Oct 27, 2023 | Substantially Equivalent | Centrix, Inc. |
| K222323 | Black Diamond | Jun 23, 2023 | Substantially Equivalent | Elevate Oral Care, LLC |
| K172047 | Riva Star | Apr 11, 2018 | Substantially Equivalent | Sdi Limited |
| K102973 | SILVER DENTAL ARREST | Jul 31, 2014 | Substantially Equivalent | Cooley Consulting, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.