Identity
- Trade Name
- iOptima APP FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). FDA UDI
- Model / Reference
- 1400063 FDA UDI
- Description
- iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). FDA UDI
Identifiers
- Catalog Number
- 1400063 FDA UDI
- Primary DI / UDI-DI
- J00714000630631 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Dental treatment application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental treatment application software
iOptima APP 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 c2c96058-8fc3-4436-a1d8-df7221bc8d1b 35 fields · synced Jun 6, 2026