Identity
- Trade Name
- B-4U INSTRUMENT FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- B-4U INSTRUMENT 2 FINISHER M L. 31 MM, CONF 6 PZ - STERILE FDA UDI
- Model / Reference
- B2231 FDA UDI
- Description
- B-4U INSTRUMENT 2 FINISHER M L. 31 MM, CONF 6 PZ - STERILE FDA UDI
Identifiers
- Catalog Number
- B2231 FDA UDI
- Primary DI / UDI-DI
- D7701488573 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rotary/reciprocating endodontic file/rasp, single-use
B-4u Instrument by Sweden & Martina Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary/reciprocating endodontic file/rasp, single-use.
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Hand Instruments — ROYDENT DENTAL PRODUCTS INC · Class I
- EdgeTaper Encore Platinum — US Endodontics, LLC · Class I
- Peeso Reamers — TULSA DENTAL PRODUCTS LLC · Class I
- MiniKut — Dental Engineering Laboratories, LLC · Class I
- EdgeTaper Blaze Utopia — MICRO MEGA · Class I
- VaryFlex Reciprocating, VFRF 50, 25mm — ENDOPERFECTION LIMITED · 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
- Sweden & Martina Inc
Sources (1)
- FDA UDI 5f7f89b8-1106-49b5-afd5-27253932a0e1 35 fields · synced May 30, 2026