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Bracket Prescription Roth - SLP .022" - 12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.13.003Model BRACKETS AND TUBES
Identity
- Trade Name
- Bracket Prescription Roth - SLP .022" - 12 EUDAMEDMorelli FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Bracket Prescription Roth - SLP .022" - 12 FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.13.003 EUDAMEDFDA UDI
- Description
- Bracket Prescription Roth - SLP .022" - 12 FDA UDI
Identifiers
- Catalog Number
- 10.13.003 FDA UDI
- Primary DI / UDI-DI
- 07895742242619 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742242619 EUDAMED7895742122FU EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Self-ligating orthodontic bracket 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthodontic tube
Bracket Prescription Roth - SLP .022" - 12 by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
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- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
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- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742242619 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742242619 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED a0932786-0ea6-41ee-be0d-12f68ef467d4 61 fields · synced Jul 23, 2026
- EUDAMED 89155f7c-fcb2-4590-a944-91b3715d186f 61 fields · synced May 16, 2026
- FDA UDI 33049c50-190b-4c04-8712-5e5ab8b2cc05 35 fields · synced May 30, 2026