← Back to catalogue
Wires & Accessories
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 621.0432Model H4 Pitts Standard TA U/L D .016 (1/10PKS)
Identity
- Trade Name
- H4 Pitts21 Standard EUDAMEDWires & Accessories FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Orthodontic Archwire EUDAMEDH4 Pitts Standard TA U/L D .016 (1/10PKS) FDA UDI
- Model / Reference
- 621.0432 EUDAMEDFDA UDIH4 Pitts Standard TA U/L D .016 (1/10PKS) EUDAMED
- Description
- H4 Pitts Standard TA U/L D .016 (1/10PKS) FDA UDI
Identifiers
- Catalog Number
- 621.0432 FDA UDI
- Primary DI / UDI-DI
- 00840273909422 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840273909422 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Orthodontic archwire
Wires & Accessories by World Class Technology Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic archwire.
- NITANIUM® RCS STRAIGHT LEGS — Ortho Organizers, Inc. · Class I
- TRUEFORM — G&H Wire Company, Inc. · Class I
- 3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
- EUROPA SOLO-PACK — G&H Wire Company, Inc. · Class I
- A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK — G&H Wire Company, Inc. · Class I
- Masel — Ortho Organizers, Inc. · Class I
- Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
- G4 EUROPA NICKEL TITANIUM — G&H Wire Company, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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
- World Class Technology Corporation
Sources (2)
- FDA UDI 6a4bb68a-ef40-48c6-9b67-d9d549869fb9 35 fields · synced Aug 1, 2026
- EUDAMED 589a75ad-01bb-4c36-b6e3-06ce386c1e17 61 fields · synced Aug 1, 2026