Identity
- Trade Name
- 20/40 Bracket EUDAMED2040 Ceramic Brackets FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- 20/40 Bracket EUDAMEDCOSMETIC 20/40 LL 1ST BIC 018 T-12 A+2 R=0 FDA UDI
- Model / Reference
- 002-2316 EUDAMEDFDA UDI
- Description
- COSMETIC 20/40 LL 1ST BIC 018 T-12 A+2 R=0 FDA UDI
Identifiers
- Catalog Number
- 002-2316 FDA UDI
- Primary DI / UDI-DI
- 00190746005756 EUDAMEDFDA UDI
- Basic UDI-DI
- 01907460000114DJ EUDAMED
- 510(k) Number
- K922499 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
- Netherlands 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
20/40 Bracket by American Orthodontics — 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 | 01907460000114DJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- American Orthodontics
- EUDAMED SRN
- US-MF-000007702
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 35e30f91-8387-43f0-9f9b-efe8e08600bf 61 fields · synced Jul 9, 2026
- FDA UDI 2814b833-52b0-4aba-ae95-3ec7a356ed59 36 fields · synced May 29, 2026