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Universal Lower Bicuspid Band With Lug Size 31
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 332-0331
Identity
- Trade Name
- UNIVERSAL LOWER BICUSPID BAND WITH LUG SIZE 31 EUDAMEDOrmco FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- UNIVERSAL LOWER BICUSPID BAND WITH LUG SIZE 31 EUDAMEDFDA UDI
- Model / Reference
- 332-0331 EUDAMEDFDA UDI
- Description
- UNIVERSAL LOWER BICUSPID BAND WITH LUG SIZE 31 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989038170 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989038170 EUDAMED
- FDA Product Code
- ECM FDA UDI
- EMDN Code
- Q010402 ORTHODONTIC BANDS EUDAMED
- GMDN Term
- Orthodontic metal band FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Universal Lower Bicuspid Band With Lug Size 31 by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989038170 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 cfe8629d-cc1e-4298-9437-8c37ade4db19 61 fields · synced Jul 23, 2026
- FDA UDI 63745c1c-fe2b-42d4-8201-2584026f5860 35 fields · synced May 30, 2026