Identity
- Trade Name
- N.A. FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Ceramic brackets conventional EUDAMEDGlam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right 0° Torque FDA UDI
- Model / Reference
- G762T1423 EUDAMEDFDA UDI
- Description
- Glam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right 0° Torque FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFORG762T14231 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EFOR070104F7 EUDAMED
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 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
No
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
Ceramic brackets conventional by Bernhard Förster GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++EFOR070104F7 | 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 6935936f-3f98-4864-b703-9bf69c9db204 61 fields · synced Jun 17, 2026
- FDA UDI bd76bb25-c640-4dd5-8dfe-ac614b41f989 34 fields · synced May 30, 2026