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Dentapure Dental Unit Water Purification Cartridge
EUDAMEDFDA UDIClass I (EU MDR)
Ref DPI365B10Model Dentapure
Identity
- Trade Name
- Dentapure Dental Unit Water Purification Cartridge EUDAMEDDentaPure Water Purification Bottle Cartridge FDA UDI
- Generic Name
- Dental waterline disinfectant cartridge FDA UDI
- Device Name
- International Water Purification Bottle Cartridge FDA UDI
- Model / Reference
- Dentapure EUDAMEDDPI365B10 EUDAMEDFDA UDI
- Description
- International Water Purification Bottle Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50732224005671 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224DENTAPURE3Q EUDAMED
- Unit of Use DI
- 00732224005676 EUDAMED
- 510(k) Number
- K992893 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental waterline disinfectant cartridge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 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
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
No
FDA UDI
Dentapure Dental Unit Water Purification Cartridge by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224DENTAPURE3Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED c81344d3-b004-4eab-b369-fdc23c975708 61 fields · synced Oct 6, 2026
- FDA UDI 8aaf33fb-e1ae-41d0-be61-042e0c88ab3f 34 fields · synced May 30, 2026