Identity
- Trade Name
- BioQuick® FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Metal bracket self-ligating EUDAMEDBioQuick Bracket Roth .018" max. 3 left FDA UDI
- Model / Reference
- -730-0303 EUDAMEDFDA UDI
- Description
- BioQuick Bracket Roth .018" max. 3 left FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFOR73003031 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EFOR070103F5 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 tube
Metal bracket self-ligating by Bernhard Förster GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
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- UP/LO 4&5 UNIV STb LIGHT LINGUAL .018 +11/0/0 — Ormco Corporation · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EFOR070103F5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bernhard Förster GmbH
- EUDAMED SRN
- DE-MF-000006256
Sources (2)
- EUDAMED 837d6a52-efc0-4c7c-887e-5a41a4805d25 61 fields · synced Aug 1, 2026
- FDA UDI 87c4290a-f49b-4e48-a24e-6e528c0bb875 34 fields · synced May 30, 2026