Identity
- Trade Name
- FM-CL-B2/B3 FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Model / Reference
- FM-CL-B2/B3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560224974311 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental handpiece coupler 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: Pneumatic dental handpiece coupler
Fm-Cl-B2/B3 by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental handpiece coupler.
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- MK-dent — MK-Dent GmbH · Class I
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- Airlight — Beyes Dental Canada Inc · Class I
- MK-dent Germany® — MK-Dent GmbH · Class I
- Airlight — Beyes Dental Canada Inc · Class I
- DENTALAIRE — Beyes Dental Canada Inc · 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
- Nakanishi Inc.
Sources (1)
- FDA UDI 1b4e162b-fcdc-4d7b-84b6-b3ce6d1ac9cc 32 fields · synced May 31, 2026