Identity
- Trade Name
- 3M™ Unitek™ FDA UDI
- Generic Name
- Orthodontic pliers FDA UDI
- Device Name
- 3M (TM) UNITEK (TM) DEBONDING INSTRUMENT FOR ULTRA SL SYSTEM FDA UDI
- Model / Reference
- 804-175 FDA UDI
- Description
- 3M (TM) UNITEK (TM) DEBONDING INSTRUMENT FOR ULTRA SL SYSTEM FDA UDI
Identifiers
- Catalog Number
- 804-175 FDA UDI
- Primary DI / UDI-DI
- 00652221236562 FDA UDI
- FDA Product Code
- JEX FDA UDI
- GMDN Term
- Orthodontic pliers FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic pliers
3M™ Unitek™ by 3m Unitek Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic pliers.
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Falcon — ORTHO TECHNOLOGY, INC. · Class I
- J&J Instruments — J&J Instruments, LLC · Class I
- FOR BENDING 45° WIRES — ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDA · Class I
- Orthopli — ORTHOPLI CORP. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Triumph® — Ortho Organizers, 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
- 3m Unitek Corporation
Sources (1)
- FDA UDI 005e0bf5-de4d-4bab-b639-0c5b8c4bd1aa 35 fields · synced Jun 1, 2026