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Upper Right Second Molar Std High Retention Band Size 13
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 651-0013
Identity
- Trade Name
- Ultralock FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- UPPER RIGHT SECOND MOLAR STD HIGH RETENTION BAND SIZE 13 EUDAMEDFDA UDI
- Model / Reference
- 651-0013 EUDAMEDFDA UDI
- Description
- UPPER RIGHT SECOND MOLAR STD HIGH RETENTION BAND SIZE 13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989056709 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989056709 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Upper Right Second Molar Std High Retention Band Size 13 by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00889989056709 | 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 25ab053a-c411-42a2-8338-61e96c9f3e9b 61 fields · synced Sep 18, 2026
- FDA UDI 523e8963-2b0b-4be9-ae11-dd1518f16d31 35 fields · synced May 30, 2026