Identity
- Trade Name
- 3M™ Unitek™ OrthoForm™ FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Unitek(TM) Permachrome Resilient Stainless Steel OrthoForm(TM) III Ovoid L .016 10/Pk FDA UDI
- Model / Reference
- 300-008 FDA UDI
- Description
- Unitek(TM) Permachrome Resilient Stainless Steel OrthoForm(TM) III Ovoid L .016 10/Pk FDA UDI
Identifiers
- Catalog Number
- 300-008 FDA UDI
- Primary DI / UDI-DI
- 00652221051387 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic archwire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic archwire
3M™ Unitek™ OrthoForm™ by 3m Unitek Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic archwire.
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- Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
- G4 EUROPA NICKEL TITANIUM — G&H Wire Company, Inc. · Class I
- ULTRAESTHETIC TRUEFORM — G&H Wire Company, 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 eebafa13-e360-4539-9f14-496d4d464cc0 35 fields · synced Jun 8, 2026