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DentaPure 365-Day Independent Water Bottle Cartridge
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- DentaPure 365-Day Independent Water Bottle Cartridge FDA UDI
- Generic Name
- Dental waterline disinfectant cartridge FDA UDI
- Device Name
- Water Purification Bottle Cartridge FDA UDI
- Model / Reference
- DP365B FDA UDI
- Description
- Water Purification Bottle Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- D711DP365B0 FDA UDI
- 510(k) Number
- K992893 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental waterline disinfectant cartridge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
DentaPure 365-Day Independent Water Bottle Cartridge by Medivators Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K992893 also covers:
- DentaPure 365-Day Independent Water Bottle Cartridge — CROSSTEX INTERNATIONAL, INC.
- DentaPure Dental Unit Water Purification Cartridge — CROSSTEX INTERNATIONAL, INC.
- DentaPure Dental Unit Water Purification Cartridge — CROSSTEX INTERNATIONAL, INC.
- DentaPure Water Purification Municipal Cartridge — CROSSTEX INTERNATIONAL, INC.
- DentaPure 365-Day Independent Water Bottle Cartridge — MEDIVATORS INC.
- DentaPure 365-Day Independent Water Bottle Cartridge — MEDIVATORS INC.
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC.
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC.
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC.
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
- Medivators Inc.
Sources (1)
- FDA UDI 61a67c91-1e56-4c39-aa87-d1f4f081200d 35 fields · synced May 30, 2026