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Ceramic brackets self-ligating
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C715-1511-010
Identity
- Trade Name
- TruKlear® FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Ceramic brackets self-ligating EUDAMEDTruKlear Bracket McLaugh/Benn/Trev. .022" mand. 4 right w. hook FDA UDI
- Model / Reference
- C715-1511-010 EUDAMEDFDA UDI
- Description
- TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 4 right w. hook FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFORC71515110101 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EFOR070105F9 EUDAMED
- Unit of Use DI
- EFORC7151511010001 EUDAMED
- 510(k) Number
- K141104 FDA UDI
- 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
No
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 self-ligating 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 | ++EFOR070105F9 | 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 157038dd-d6f7-4457-9cf6-bbf3fce13eee 61 fields · synced Jul 14, 2026
- FDA UDI 44944923-8d41-4da7-adda-3edaf92d025e 35 fields · synced May 30, 2026