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Spark Advanced - Refinement
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 728-3032Model 728-*
Identity
- Trade Name
- SPARK ADVANCED - REFINEMENT EUDAMEDSpark FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- SPARK * EUDAMEDSpark Advanced - Refinement FDA UDI
- Model / Reference
- 728-* EUDAMED728-3032 EUDAMEDFDA UDI
- Description
- Spark Advanced - Refinement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989084863 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-Sprk_Clr_Align-48 EUDAMED
- FDA Product Code
- NXC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Spark Advanced - Refinement by Ormco Corporation — Class IIa — 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-Sprk_Clr_Align-48 | 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 ae385bef-e4e1-4f58-b1ef-60bed29a2cbf 61 fields · synced Aug 4, 2026
- FDA UDI b8edf4fa-485c-48e9-9b93-068c71dd103b 34 fields · synced May 30, 2026