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Ball Tip Hook Universal For Wires Up To .022''
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30.40.009Model ACCESSORIES - Class IIa
Identity
- Trade Name
- Ball Tip Hook Universal For Wires Up To .022'' EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic lock FDA UDI
- Device Name
- Ball Tip Hook Universal For Wires Up To .022'' FDA UDI
- Model / Reference
- ACCESSORIES - Class IIa EUDAMED30.40.009 EUDAMEDFDA UDI
- Description
- Ball Tip Hook Universal For Wires Up To .022'' FDA UDI
Identifiers
- Catalog Number
- 30.40.009 FDA UDI
- Primary DI / UDI-DI
- 07895742154790 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742183GG EUDAMEDB-07895742154790 EUDAMED
- FDA Product Code
- ECN FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic lock 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
Category: Orthodontic retainer
Ball Tip Hook Universal For Wires Up To .022'' by Dental Morelli Ltda. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthodontic retainer.
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- ELASTICO CORRENTE LONGO PINK CRISTAL RL 4, 5M — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Pre-Finisher — TP ORTHODONTICS, INC. · Class I
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742183GG | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742183GG | 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 bcb0154b-fbc4-431f-b093-7700a1448fff 61 fields · synced Jun 18, 2026
- EUDAMED 5dc4bf42-6292-475f-b5a6-9093553c8389 61 fields · synced May 19, 2026
- FDA UDI 9675df0e-c2dd-4dd9-8810-832fa67413a5 35 fields · synced May 30, 2026