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Spark 20 - Single Arch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 728-3021Model 728-*
Identity
- Trade Name
- SPARK 20 - SINGLE ARCH EUDAMEDSpark FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- SPARK * EUDAMEDSpark 20 / Active - Single Arch FDA UDI
- Model / Reference
- 728-* EUDAMED728-3021 EUDAMEDFDA UDI
- Description
- Spark 20 / Active - Single Arch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989084825 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 20 - Single Arch 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 fd5148ba-e7a5-4c3f-b9ad-6e044865feb7 61 fields · synced Jun 18, 2026
- FDA UDI 2143cc21-a26a-456c-a5b4-82426abfc6ee 34 fields · synced May 29, 2026