Identity
- Trade Name
- Zoral FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM # MAK-1310). Zoral System is attached to the dental unit's quick disconnect air to pressurize the Zoral System. FDA UDI
- Model / Reference
- 00854542008372 FDA UDI
- Description
- Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM # MAK-1310). Zoral System is attached to the dental unit's quick disconnect air to pressurize the Zoral System. FDA UDI
Identifiers
- Catalog Number
- item # MAK-1310 FDA UDI
- Primary DI / UDI-DI
- 00854542008211 FDA UDI
- 510(k) Number
- K023213 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, pneumatic 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 instrument unit, pneumatic
Zoral 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 00cde302-0920-4157-86d3-2422b1c5d0ee 36 fields · synced May 31, 2026