Identity
- Trade Name
- 3D FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- 3D BIMETRIC ARCH ASSORTMENT FDA UDI
- Model / Reference
- K00688 FDA UDI
- Description
- 3D BIMETRIC ARCH ASSORTMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797100078 FDA UDI
- FDA Product Code
- DYT FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 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
Yes
FDA UDI
Category: Orthodontic bracket, metal
3d by Rmo — 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
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, INC. · Class I
- 3M™ Victory Series™ — 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
- Rmo
Sources (1)
- FDA UDI b315a438-f8b5-47e2-bec1-87200737c8d9 33 fields · synced Jun 8, 2026