Identity
- Trade Name
- Maint Aquacare (Single Can) FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments FDA UDI
- Model / Reference
- 1600617-001 FDA UDI
- Description
- Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments FDA UDI
Identifiers
- Catalog Number
- 1600617-001 FDA UDI
- Primary DI / UDI-DI
- J00716006170011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Surgical instrument maintenance lubricant 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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument maintenance lubricant
Maint Aquacare (Single Can) by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument maintenance lubricant.
- Service Oil and Cleaning Solution MB-301 — W & H Dentalwerk Bürmoos GmbH · Class I
- Sklar® — Sklar Corporation · Class I
- ContraClean — Stryker Corp. · Class I
- CURVTEK LUBRICANT, 1OZ — Biomet Orthopedics, Inc. · Class I
- Sky-Lube — Skytron, LLC · Class II
- Primado2 — NAKANISHI INC. · Class I
- Surgical Milk — Germiphene Corp. · Class I
- PREMIXSLIP (4.2oz/125ml with mister) — Ruhof Corporation · Class I
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
- Bien-Air Dental SA
Sources (1)
- FDA UDI 730a9ac3-a17a-487b-b25f-aff6afe4e085 35 fields · synced May 30, 2026