Identity
- Trade Name
- DYNA-LINK™ EUDAMEDDYNA-LINK FDA UDI
- Generic Name
- Orthodontic inter-bracket elastic chain FDA UDI
- Device Name
- Elastic Chain EUDAMEDBLACK DYNA-LINK CONTINUOUS FDA UDI
- Model / Reference
- CDLBK EUDAMEDFDA UDI
- Description
- BLACK DYNA-LINK CONTINUOUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886102152 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190886ElasticChainBM EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic inter-bracket elastic chain FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic retainer
Dyna-Link™ by G&H Wire Company, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic retainer.
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
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- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Pre-Finisher — TP ORTHODONTICS, INC. · Class I
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0190886ElasticChainBM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
- EUDAMED SRN
- US-MF-000012129
- Authorised Representative
- G&H Europe BV NL-AR-000022839
Sources (2)
- EUDAMED 70322d0d-0b17-4337-967d-958c1d5ed48b 61 fields · synced Jul 10, 2026
- FDA UDI 5c93461f-95a8-4f6e-a80b-710e964ced09 34 fields · synced May 30, 2026