Identity
- Trade Name
- WaterlineX® FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- WaterlineX® is a closed pressurized dental bottle system capable of supplying dental unit water, a cleaning solution or pressurized air to the dental unit waterlines. The system can be used with solutions to clean the dental unit waterlines by air purging and/or injecting a cleaning solution (ITEM #: MAK-1806). System includes a heavy duty dental unit water bottle. FDA UDI
- Model / Reference
- (01)854542008167(10)204008 FDA UDI
- Description
- WaterlineX® is a closed pressurized dental bottle system capable of supplying dental unit water, a cleaning solution or pressurized air to the dental unit waterlines. The system can be used with solutions to clean the dental unit waterlines by air purging and/or injecting a cleaning solution (ITEM #: MAK-1806). System includes a heavy duty dental unit water bottle. FDA UDI
Identifiers
- Catalog Number
- ITEM #: MAK-1806 FDA UDI
- Primary DI / UDI-DI
- 00854542008167 FDA UDI
- 510(k) Number
- K023896 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system
WaterlineX® by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Anodia Systems
Sources (1)
- FDA UDI b4738b74-c2c5-4a55-9467-dd3ecd3f0cb9 36 fields · synced May 30, 2026