Identity
- Trade Name
- Steri-Sol® Dental Handpiece Cutting Solution FDA UDI
- Generic Name
- Dental scaling solution FDA UDI
- Device Name
- Dental Handpiece Cutting/Fluid solution for use with air or electrically driven Dental High-Speed & Dental Low-Speed Handpiece operative procedures (Net contents: 32 fl. ounces) FDA UDI
- Model / Reference
- 00854542008334 FDA UDI
- Description
- Dental Handpiece Cutting/Fluid solution for use with air or electrically driven Dental High-Speed & Dental Low-Speed Handpiece operative procedures (Net contents: 32 fl. ounces) FDA UDI
Identifiers
- Catalog Number
- ITEM # MAK-STERI-SOL FDA UDI
- Primary DI / UDI-DI
- 00854542008334 FDA UDI
- 510(k) Number
- K925378 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental scaling solution FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Dental scaling solution
Steri-Sol® Dental Handpiece Cutting Solution by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental scaling solution.
- SofScale™ — Dentsply Professional · Class II
- SofScale™ — Dentsply Professional · Class II
- Zoral Scaler Solution® — Anodia Systems · Class I
- Zoral Scaler Solution® — Anodia Systems · Class I
Cleared under the same submission
K925378 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Anodia Systems
Sources (1)
- FDA UDI e51a4af6-cf0a-444d-9457-fcce5654e4bb 36 fields · synced May 30, 2026