Identity
- Trade Name
- MARA Upper Tube (2Pk) FDA UDI
- Generic Name
- Orthodontic power arm FDA UDI
- Model / Reference
- 901411 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8199014110 FDA UDI
- FDA Product Code
- ECN FDA UDI
- GMDN Term
- Orthodontic power arm 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic power arm
MARA Upper Tube (2Pk) by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic power arm.
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- Power Pin — TP ORTHODONTICS, INC. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- CRIMPABLE HOOK — TP ORTHODONTICS, INC. · 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
- Specialty Appliances, Llc
Sources (1)
- FDA UDI a649c3bc-9b09-47c1-b808-7db6b6e59d37 32 fields · synced May 31, 2026