Identity
- Trade Name
- PRO CLEAN STAIN CLEANER (SINGLE BOX of 25) EUDAMEDPro Clean FDA UDI
- Generic Name
- Denture cleanser FDA UDI
- Device Name
- Pro Clean EUDAMEDPRO CLEAN STAIN CLEANER (SINGLE BOX of 25) FDA UDI
- Model / Reference
- 9011103 EUDAMEDFDA UDI
- Description
- PRO CLEAN STAIN CLEANER (SINGLE BOX of 25) FDA UDI
Identifiers
- Catalog Number
- 9011103 FDA UDI
- Primary DI / UDI-DI
- 00348783003826 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783ProCleanAK EUDAMED
- FDA Product Code
- JER FDA UDI
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
- GMDN Term
- Denture cleanser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3530 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Denture cleanser
Pro Clean by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 8a437024-9eb0-4b21-99a6-0c2765240137 34 fields · synced Jul 11, 2026
- EUDAMED 7b38c07d-a4ce-4d4a-9e2e-ca59ed552307 61 fields · synced Jul 11, 2026