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Kit of Brackets 10 cases Prescription Roth - Max .018" - Can. 9° Ang. - Hook Ca…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.15.932Model BRACKETS AND TUBES
Identity
- Trade Name
- Kit of Brackets 10 cases Prescription Roth - Max .018" - Can. 9° Ang. - Hook Can./Bicusp. EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Kit of Brackets 10 cases Prescription Roth - Max .018" - Can. 9° Ang. - Hook Can./Bicusp. FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.15.932 EUDAMEDFDA UDI
- Description
- Kit of Brackets 10 cases Prescription Roth - Max .018" - Can. 9° Ang. - Hook Can./Bicusp. FDA UDI
Identifiers
- Catalog Number
- 10.15.932 FDA UDI
- Primary DI / UDI-DI
- 07895742207199 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742207199 EUDAMED7895742122FU 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
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
Kit of Brackets 10 cases Prescription Roth - Max .018" - Can. 9° Ang. - Hook Ca… by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED…
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-07895742207199 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742207199 | 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 b2dbe4b4-260c-4267-81d6-dac47eee3086 61 fields · synced Oct 6, 2026
- EUDAMED 5a0a5a71-8f70-4650-a159-85c11949faeb 61 fields · synced May 19, 2026
- FDA UDI 87beaed7-6252-4aa6-96bd-38f8897a2772 35 fields · synced May 29, 2026