Identity
- Trade Name
- Abso Answer FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Model / Reference
- AA-18-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806145476111 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal 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
Yes
FDA UDI
Category: Orthodontic bracket, metal
Abso Answer by DENTOS Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, metal.
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Intrigue — LANCER ORTHODONTICS, INC. · Class II
- The Orthodontic Store — Young Innovations, Inc. · Class I
- LEGEND — GC Orthodontics America Inc. · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- RMO — RMO · Class I
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DENTOS Inc.
Sources (1)
- FDA UDI 2f4f0633-2b56-48e9-a629-d8d828ab1ab9 32 fields · synced Jun 6, 2026