Metal Self Ligating Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC U-CLIP BRACKET FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Metal Self Ligating Brackets EUDAMEDSELF LIGATING BRACKET ORTHOCLIP SLB U-CLIP MBT 0,022”- L 3 R- 5 UN FDA UDI
- Model / Reference
- 11.45.2343 EUDAMEDFDA UDI
- Description
- SELF LIGATING BRACKET ORTHOCLIP SLB U-CLIP MBT 0,022”- L 3 R- 5 UN FDA UDI
Identifiers
- Catalog Number
- 11.45.2343 FDA UDI
- Primary DI / UDI-DI
- 07908611200709 EUDAMEDFDA UDI
- Basic UDI-DI
- 79084707SELFLIGATINGEZ 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
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthodontic tube
Metal Self Ligating Brackets by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED…
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
- L4R BRACANIC CAPELOZZA I .022 PC C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 79084707SELFLIGATINGEZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED 6e0d343a-f6d8-4f36-a696-d64b786ba790 61 fields · synced Jul 23, 2026
- FDA UDI 78003182-6cae-40af-870d-54249087d2f7 34 fields · synced May 27, 2026