Identity
- Trade Name
- Set MC3 LED + 4VR400 Grey FDA UDI
- Generic Name
- Remotely-driven dental drilling system motor FDA UDI
- Device Name
- Set of micromotor with hose FDA UDI
- Model / Reference
- 1700445-001 FDA UDI
- Description
- Set of micromotor with hose FDA UDI
Identifiers
- Catalog Number
- 1700445-001 FDA UDI
- Primary DI / UDI-DI
- J00717004450011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Remotely-driven dental drilling system motor 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
Yes
FDA UDI
Category: Remotely-driven dental drilling system motorPneumatic dental power tool hose
Set MC3 LED + 4VR400 Grey by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental power tool hose.
- Hose MX2 Grey — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- Set MC3 LED + Hose for Kavo — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE 4VR400 GREY MIDWEST — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE 4VX GREY (16x27) — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE ISOLITE/MC2 SWIVEL BLACK — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE 4VR400 SURF6 ADEC — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE MX2 400 SURF 6 — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- HOSE 6 HOLE L GREY MIDWEST — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · 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 |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
Sources (1)
- FDA UDI 40635c85-e5f1-412c-bd09-999d0a32e497 35 fields · synced May 30, 2026