Identity
- Trade Name
- ELASTIC THREAD FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- ELAS THREAD SMOOTH 025X25 GREY FDA UDI
- Model / Reference
- 89-4122-0000 FDA UDI
- Description
- ELAS THREAD SMOOTH 025X25 GREY FDA UDI
Identifiers
- Catalog Number
- 89-4122-0000 FDA UDI
- Primary DI / UDI-DI
- D78889412200001 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic archwire/bracket ligature 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic archwire/bracket ligature
Elastic Thread by GC Orthodontics America Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic archwire/bracket ligature.
- SELECT-TIES — G&H Wire Company, Inc. · Class I
- AURADONICS — AURADONICS INC. · Class I
- Kobayashi Tie Hooks — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- 3M™ AlastiK™ — 3M UNITEK CORPORATION · Class I
- Mini Stix Ligature Ties — TP ORTHODONTICS, INC. · Class I
- MINI-TIES — Ortho Organizers, Inc. · Class I
- Plak Smacker — Young Innovations, Inc. · Class I
- PHOENIX — AURADONICS INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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
- GC Orthodontics America Inc.
Sources (2)
- FDA UDI 0d81e4fd-dd0e-4b8c-950e-ab6863bdbfd8 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026