Identity
- Trade Name
- ScanX Intraoral View FDA UDI
- Generic Name
- Radiography digital imaging scanner FDA UDI
- Model / Reference
- G8600 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E247G86000 FDA UDI
- 510(k) Number
- K170733 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiography digital imaging scanner
ScanX Intraoral View by Durr Dental AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiography digital imaging scanner.
- ScanX Classic for Intraoral & Extraoral Imaging — Air Techniques, Inc. · Class II
- Vidar Systems Corporation — Vidar Systems Corp. · Class II
- ScanX Fit (with battery) — Air Techniques, Inc. · Class II
- Vidar Systems Corporation — Vidar Systems Corp. · Class II
- ScanX Swift View — DÜRR DENTAL SE · Class II
- ScanX Fit (without battery) — Air Techniques, Inc. · Class II
- ScanX Swift Digital Imaging System — Air Techniques, Inc. · Class II
- FireCR — DIGIRAY Corp. · Class II
Cleared under the same submission
K170733 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Durr Dental AG
Sources (1)
- FDA UDI b3fd5954-27fe-437e-82d0-a5447c25630c 33 fields · synced Jun 7, 2026