Identity
- Trade Name
- Elastic Chain FDA UDI
- Generic Name
- Orthodontic inter-bracket elastic chain FDA UDI
- Device Name
- ELASTIC CHAIN CLEAR LONG FDA UDI
- Model / Reference
- 4108-588 FDA UDI
- Description
- ELASTIC CHAIN CLEAR LONG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707015022 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic inter-bracket elastic chain 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 inter-bracket elastic chain
This device is an elastic chain used in orthodontic treatment for single-patient use, replacing the archwire/bracket ligature on several adjacent teeth. It functions as a continuous light force to close spaces between teeth and is made of elastomeric material.
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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
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI b9d3b8cc-85e6-4db8-be47-ccfaa9096d4a 33 fields · synced Jul 15, 2026