Identity
- Trade Name
- DentaPure Dental Unit Water Purification Cartridge FDA UDI
- Generic Name
- Dental waterline disinfectant cartridge FDA UDI
- Device Name
- 365 day independent water filter FDA UDI
- Model / Reference
- DP365B FDA UDI
- Description
- 365 day independent water filter FDA UDI
Identifiers
- Catalog Number
- DP365B FDA UDI
- Primary DI / UDI-DI
- 10732224005505 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
- 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
Category: Dental waterline disinfectant cartridge
DentaPure Dental Unit Water Purification Cartridge by Crosstex International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental waterline disinfectant cartridge.
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC. · Class I
- BluTube 90 Day Cartridge — PROEDGE DENTAL PRODUCTS, INC. · Class I
- BluTube 180 Day Cartridge — PROEDGE DENTAL PRODUCTS, INC. · Class I
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC. · Class I
- DentaPure 365-Day Independent Water Bottle Cartridge — MEDIVATORS INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- DentaPure 365-Day Independent Water Bottle Cartridge — MEDIVATORS INC. · Class I
- DentaPure 365-Day Municipal Cartridge — MEDIVATORS INC. · Class I
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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Crosstex International, Inc.
Sources (1)
- FDA UDI 05059116-3929-46bf-82b9-14622453001e 36 fields · synced Jun 8, 2026