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ClinCheck Pro 6
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SW-0000159Model SW-0000159
Identity
- Trade Name
- ClinCheck Pro 6 EUDAMEDClinCheck FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Invisalign Dental Planning Software EUDAMED3D Treatment Planning Software - ClinCheck Pro 6 FDA UDI
- Model / Reference
- SW-0000159 EUDAMEDFDA UDI
- Description
- 3D Treatment Planning Software - ClinCheck Pro 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021360 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302ClinCheckKM EUDAMED
- 510(k) Number
- K181739 FDA UDI
- FDA Product Code
- PNN FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ClinCheck Pro 6 by Align Technology, Inc. — 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 | 081606302ClinCheckKM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED 309d0e1e-35bc-497f-8564-9613f31564bc 61 fields · synced Jun 18, 2026
- FDA UDI e1c6c682-396b-4944-9447-9ae80cbb678b 34 fields · synced May 30, 2026