Identity
- Trade Name
- PRO-KLEEN FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- PRO-KLEEN is a pressurized dental unit waterline cleaning system designed to clean dental units on city water that do not have a dental unit water bottle system (Manufacturer # MAK-1910). Toggle switch controls Air Purge or liquid dental waterline cleaning solution injection. FDA UDI
- Model / Reference
- 854542008037 FDA UDI
- Description
- PRO-KLEEN is a pressurized dental unit waterline cleaning system designed to clean dental units on city water that do not have a dental unit water bottle system (Manufacturer # MAK-1910). Toggle switch controls Air Purge or liquid dental waterline cleaning solution injection. FDA UDI
Identifiers
- Catalog Number
- MAK-1910 FDA UDI
- Primary DI / UDI-DI
- 00854542008037 FDA UDI
- 510(k) Number
- K023815 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system
Pro-Kleen by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023815 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 42fe860c-4ac3-481d-b384-6eeb48fd31b1 36 fields · synced May 30, 2026