Identity
- Trade Name
- DentaPure Water Purification Bottle Cartridge FDA UDI
- Generic Name
- Dental waterline disinfectant cartridge FDA UDI
- Device Name
- Water Purification Bottle Cartridge FDA UDI
- Model / Reference
- *DP40B10 FDA UDI
- Description
- Water Purification Bottle Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50732224005527 FDA UDI
- 510(k) Number
- K992868 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 Water Purification Bottle 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.
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- 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
K992868 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Crosstex International, Inc.
Sources (1)
- FDA UDI a3fb76e1-86fa-4beb-b272-7c418c1da1eb 35 fields · synced Jun 8, 2026