Chrysalis Intelligence · Product Codes · PHR

PHR · Diammine Silver Fluoride Dental Hypersensitivity Varnish

Dental · 6 clearances · 6 unique sponsors

Device class
Class II
Regulation 872.3260
Total clearances
6
2023-06-23 → 2025-05-07
Last 12 months
0
Unique sponsors
6
Definition

What is Diammine Silver Fluoride Dental Hypersensitivity Varnish

Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Medical specialty
Dental
Review panel
DE
Regulation number
872.3260
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Elevate Oral Care, LLC 1 0 2023-06-23
Centrix, Inc. 1 0 2023-10-27
Young Dental Manufacturing Co. 1, LLC 1 0 2025-02-28
Tedequim Srl 1 0 2024-05-16
Belport Company, Inc., Gingi-Pak 1 0 2025-05-07
Kids-E-Dental Llp 1 0 2024-03-06
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
99070 CPT Medium Miscellaneous supplies/equipment not otherwise specified; dental varnish supply/application
D1206 CDT Medium Topical fluoride application (varnish); topical desensitizing agent application
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-07 K250222 Belport Company, Inc., Gingi-Pak SDF Pro
2025-02-28 K241041 Young Dental Manufacturing Co. 1, LLC Silver Fluoride Hypersensitivity Varnish
2024-05-16 K240059 Tedequim Srl FAgamin®
2024-03-06 K240619 Kids-E-Dental Llp e-SDF
2023-10-27 K222459 Centrix, Inc. Centrix FluoroSilver Silver Diamine Fluoride 38%
2023-06-23 K222323 Elevate Oral Care, LLC Black Diamond