Identity
- Trade Name
- DentaKLEEN® FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- DentaKLEEN is used for dental units on city water in which the dental lines are to be cleaned (Manufacturer # MAK-1900). Designed with toggle switches allowing the dental personnel to have complete control of the cleaning. One toggle switch controls the incoming water to the dental unit in reference to being on or off. The other toggle switch allows the dental personnel to air purge the waterlines and then inject a liquid cleaner into the waterlines. FDA UDI
- Model / Reference
- (01)00854542008150(10)3030951384 FDA UDI
- Description
- DentaKLEEN is used for dental units on city water in which the dental lines are to be cleaned (Manufacturer # MAK-1900). Designed with toggle switches allowing the dental personnel to have complete control of the cleaning. One toggle switch controls the incoming water to the dental unit in reference to being on or off. The other toggle switch allows the dental personnel to air purge the waterlines and then inject a liquid cleaner into the waterlines. FDA UDI
Identifiers
- Catalog Number
- ITEM #: MAK-1900 FDA UDI
- Primary DI / UDI-DI
- 00854542008150 FDA UDI
- 510(k) Number
- K023815 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
DentaKLEEN® by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023815 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 |
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Manufacturer
- Manufacturer
- Anodia Systems
Sources (1)
- FDA UDI c3f63079-b000-42bb-8eed-1470dc2878ab 36 fields · synced Jun 8, 2026