Identity
- Trade Name
- SureSmile Aligner Software 7.6 EUDAMEDSureSmile Aligner Software FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- SureSmile Software EUDAMED
- Model / Reference
- DIGI-500152 EUDAMED7.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856379007085 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856379007DIGI500CF EUDAMED
- Direct Marketing DI
- 00856379007085 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110182 INSTRUMENTS FOR DENTAL TREATMENT UNITS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CAD/CAM software
SureSmile Aligner Software by Orametrix, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orametrix, Inc.
Sources (2)
- FDA UDI ae04ed76-7080-45c8-9d38-2fb4e1e8d767 33 fields · synced Jul 30, 2026
- EUDAMED 98b8a675-b15b-4d2a-a4f0-56881d4e1442 61 fields · synced Jul 30, 2026