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Ceramic brackets conventional
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref G764-0313-010
Identity
- Trade Name
- N.A. FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Ceramic brackets conventional EUDAMEDGlam Ceramic Bracket Roth .018" max. 3 right w. hook FDA UDI
- Model / Reference
- G764-0313-010 EUDAMEDFDA UDI
- Description
- Glam Ceramic Bracket Roth .018" max. 3 right w. hook FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFORG76403130101 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EFOR070104F7 EUDAMED
- Unit of Use DI
- EFORG7640313010001 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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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 | ++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 17649dce-646d-4bbd-8aa2-f0849cd70888 61 fields · synced Jul 15, 2026
- FDA UDI 014d5b5d-f10a-4879-b72d-34048412ce9c 34 fields · synced May 30, 2026