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Angulated Bracket Remover
EUDAMEDFDA UDIClass I (EU MDR)
Ref 803-0104Model 8**-
Identity
- Trade Name
- ANGULATED BRACKET REMOVER EUDAMEDOrmco FDA UDI
- Generic Name
- Orthodontic pliers FDA UDI
- Device Name
- DEBONDING/REPOSITIONING INSTRUMENT EUDAMEDANGULATED BRACKET REMOVER FDA UDI
- Model / Reference
- 8**- EUDAMED803-0104 EUDAMEDFDA UDI
- Description
- ANGULATED BRACKET REMOVER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989075786 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-HI_Debonding-C2 EUDAMED
- FDA Product Code
- JEX FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthodontic pliers FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Angulated Bracket Remover by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-HI_Debonding-C2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 30d43268-10b2-40f8-a7a8-6a1c333e9346 61 fields · synced Jul 9, 2026
- FDA UDI fac32a77-7f59-4e8c-baab-00eaa0166878 34 fields · synced May 29, 2026