Identity
- Trade Name
- Elastic, Orthodontic FDA UDI
- Generic Name
- Orthodontic inter-bracket elastic chain FDA UDI
- Device Name
- A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use). FDA UDI
- Model / Reference
- Elastics FDA UDI
- Description
- A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use). FDA UDI
Identifiers
- Primary DI / UDI-DI
- D183241 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
Yes
FDA UDI
Prescription Use
No
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 inter-bracket elastic chain
Elastic, Orthodontic by Tenco — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic inter-bracket elastic chain.
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- AURADONICS — AURADONICS INC. · Class I
- 3M™ AlastiK™ — 3M UNITEK CORPORATION · 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
- Tenco
Sources (1)
- FDA UDI 7a243b14-b163-408a-a803-5a7980a2db4c 33 fields · synced Jun 1, 2026