Identity
- Trade Name
- Lubricare Maintenance System FDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Device Name
- Device used to maintain optimum performance and prolong working life of dental handpieces. Delivers oli and air automatically to the handpiece and is used after dental treatement before autoclaving FDA UDI
- Model / Reference
- 1600915-001 FDA UDI
- Description
- Device used to maintain optimum performance and prolong working life of dental handpieces. Delivers oli and air automatically to the handpiece and is used after dental treatement before autoclaving FDA UDI
Identifiers
- Catalog Number
- 1600915-001 FDA UDI
- Primary DI / UDI-DI
- J0071600915011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental handpiece maintenance unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument maintenance lubricantDental handpiece maintenance unit
Lubricare Maintenance System by Bien-Air Dental SA — 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
- Bien-Air Dental SA
Sources (1)
- FDA UDI 79865eb6-ee15-48ae-8045-e0cafc3c2daf 35 fields · synced May 30, 2026