Diammine Silver Fluoride Dental Hypersensitivity Varnish
Dental · 21 CFR 872.3260
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Trend for “Adverse Event Without Identified Device or Use Problem”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
12 firms currently registered for this product code
Nusmile, Ltd
HOUSTON, TX, US
Medmix Deutschland Gmbh
Kiel Schleswig-Holstein, DE
Sdi Ltd.
BAYSWATER Victoria, AU
Elevate Oral Care, Llc
West Palm Beach, FL, US
Baron Analytical Laboratories Llc
Milford, CT, US
Young Dental Manufacturing Co 1, Llc.
EARTH CITY, MO, US
Centrix, Inc.
Shelton, CT, US
Kids-e-dental Llp
Mumbai Maharashtra, IN
Hexa Dental
Commerce, CA, US
Organic Consultants, Llc
Eugene, OR, US
510(k) clearances
8 clearances for this product code
- Belport Company, Inc., Gingi-PakMay 7, 2025
K250222 · SDF Pro
- Young Dental Manufacturing Co. 1, LLCFeb 28, 2025
K241041 · Silver Fluoride Hypersensitivity Varnish
- Tedequim SrlMay 16, 2024
K240059 · FAgamin®
- Kids-E-Dental LlpMar 6, 2024
K240619 · e-SDF
- Centrix, Inc.Oct 27, 2023
K222459 · Centrix FluoroSilver Silver Diamine Fluoride 38%
- Elevate Oral Care, LLCJun 23, 2023
K222323 · Black Diamond
- Sdi LimitedApr 11, 2018
K172047 · Riva Star
- Cooley Consulting, Inc.Jul 31, 2014
K102973 · SILVER DENTAL ARREST