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Band Seater with Invertible Triangular Tip
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.012Model REUSABLE INSTRUMENTS
Identity
- Trade Name
- Band Seater with Invertible Triangular Tip EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic metal band pusher FDA UDI
- Device Name
- Band Seater with Invertible Triangular Tip FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED75.01.012 EUDAMEDFDA UDI
- Description
- Band Seater with Invertible Triangular Tip FDA UDI
Identifiers
- Catalog Number
- 75.01.012 FDA UDI
- Primary DI / UDI-DI
- 07895742008833 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742008833 EUDAMED7895742133FZ EUDAMED
- FDA Product Code
- ECS FDA UDI
- EMDN Code
- L150704 ORTHODONTIC BAND PUSHERS, REUSABLE EUDAMED
- GMDN Term
- Orthodontic metal band pusher FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Dry Heat Sterilization FDA UDI
Band Seater with Invertible Triangular Tip by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-07895742008833 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742008833 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 6cd964c3-ceaf-41d4-a730-82145b2aa8a6 61 fields · synced Jul 17, 2026
- EUDAMED a1dbbe8d-9970-43c5-acbd-a8dab01c9b82 61 fields · synced May 19, 2026
- FDA UDI 84e5e3f7-3a91-4db4-8985-911d3164b36d 35 fields · synced May 29, 2026