Identity
- Trade Name
- SureSmile Advanced Software 7.6 EUDAMEDSureSmile Advanced Software FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- SureSmile Software EUDAMEDSureSmile Advanced Software FDA UDI
- Model / Reference
- DIGI-500159 EUDAMED7.6 FDA UDI
- Description
- SureSmile Advanced Software FDA UDI
Identifiers
- Catalog Number
- DIGI-500159 FDA UDI
- Primary DI / UDI-DI
- 00856379007108 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856379007DIGI500CF EUDAMED
- Direct Marketing DI
- 00856379007108 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 Advanced Software by Orametrix, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as CAD/CAM software.
- CEREC — Sirona Dental Systems GmbH · Class II
- DTX Studio™ Lab — Nobel Biocare AG · Class II
- SurgiCase Planner — Materialise NV · Class II
- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- Mimics — Materialise NV · Class II
- ProPlan CMF — Materialise NV · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orametrix, Inc.
Sources (2)
- FDA UDI 988ce3e3-6ae2-4c38-9a72-86cba09e9047 35 fields · synced Jul 31, 2026
- EUDAMED d7ea90c0-9b6a-4e3a-ba6f-f28f37c222bb 61 fields · synced Jul 31, 2026