Identity
- Trade Name
- PREVA GERMAN MOBILE SYSTEM, WHITE FDA UDI
- Generic Name
- Mobile intraoral dental x-ray system, digital FDA UDI
- Device Name
- Intraoral X-ray, Mobile FDA UDI
- Model / Reference
- PE7017DM-W FDA UDI
- Description
- Intraoral X-ray, Mobile FDA UDI
Identifiers
- Catalog Number
- PE7017DM-W FDA UDI
- Primary DI / UDI-DI
- 00841709103520 FDA UDI
- 510(k) Number
- K043092 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Mobile intraoral dental x-ray system, digital 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: Mobile intraoral dental x-ray system, digital
Preva German Mobile System, White by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile intraoral dental x-ray system, digital.
- IntraOs DG — BLUO ELECTRONICS SRL · Class II
- Owandy-RX DC — OWANDY RADIOLOGY · Class II
- Owandy-RX DC — OWANDY RADIOLOGY · Class II
- Vario DG — BLUO ELECTRONICS SRL · Class II
- XZeal Z70 Mobile VET — XZEAL TECHNOLOGIES, INC. · Class II
- x-mind dc — DE GÖTZEN SRL · Class II
- IntraOs 70 — BLUO ELECTRONICS SRL · Class II
- Rayos DC — Skanray Technologies · Class II
Cleared under the same submission
K043092 also covers:
- CONTROL UNIT ASM., PREVA 2.0 RAL 9010 — Midmark Corporation
- CONTROL UNIT, PREVA 2.0 MOBILE STAND — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA UDI fc8fdc29-7434-4fe3-8b8b-572e60e207ae 37 fields · synced Jun 8, 2026