Identity
- Trade Name
- EVA SELECT DIRECT FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- EVA SELECT DIRECT SIZE 2 SYSTEM FDA UDI
- Model / Reference
- 9992413200 FDA UDI
- Description
- EVA SELECT DIRECT SIZE 2 SYSTEM FDA UDI
Identifiers
- Catalog Number
- 9992413200 FDA UDI
- Primary DI / UDI-DI
- D83399924132000 FDA UDI
- 510(k) Number
- K123419 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- General-purpose dental x-ray system application software 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoralGeneral-purpose dental x-ray system application software
Eva Select Direct by ImageWorks — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose dental x-ray system application software.
- Ez3D-i — Ewoosoft Co., Ltd. · Class II
- Midmark Progeny Imaging Software — Midmark Corporation · Class II
- Visix — Televere Systems · Class II
- TigerView — Televere Systems · Class II
- VisionX — DÜRR DENTAL SE · Class II
- Visix — Televere Systems · Class II
- EzDent-i — Ewoosoft Co., Ltd. · Class II
- ImageXL — PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC · Class II
Cleared under the same submission
K123419 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
- ImageWorks
Sources (1)
- FDA UDI 4d319dcb-1a2f-4d25-867b-b4d3d5246b2b 35 fields · synced May 31, 2026