Identity
- Trade Name
- SofScale™ FDA UDI
- Generic Name
- Dental scaling solution FDA UDI
- Device Name
- SofScale™ Calculus Scaling Gel, 25 Syringes (2mL) and 25 Disposable Applications Tips. FDA UDI
- Model / Reference
- A900300 FDA UDI
- Description
- SofScale™ Calculus Scaling Gel, 25 Syringes (2mL) and 25 Disposable Applications Tips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D003A9003001 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental scaling solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Dental scaling solution
SofScale™ by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental scaling solution.
- Zoral Scaler Solution® — Anodia Systems · Class I
- Zoral Scaler Solution® — Anodia Systems · Class I
- Steri-Sol® Dental Handpiece Cutting Solution — Anodia Systems · Class I
- SofScale™ — Dentsply Professional · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Professional
Sources (1)
- FDA UDI f40db8ad-07c8-45cf-a6ae-5e238c16fb4f 36 fields · synced Jun 8, 2026