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Midmark PREVA IntraOral Dental X-ray System

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark PREVA IntraOral Dental X-ray System FDA UDI
Generic Name
Mobile specimen x-ray system, analogue FDA UDI
Device Name
Intraoral X-ray FDA UDI
Model / Reference
DCD6DE-W2X/H/S2 FDA UDI
Description
Intraoral X-ray FDA UDI

Identifiers

Catalog Number
DCD6DE-W2X/H/S2 FDA UDI
Primary DI / UDI-DI
00841709101731 FDA UDI
510(k) Number
K043092 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Mobile specimen x-ray system, analogue 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

Yes

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 specimen x-ray system, analogue

Midmark PREVA IntraOral Dental X-ray System by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K043092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI 310fca99-a18a-4c70-b5be-a11d0bdd664c 37 fields · synced Jun 8, 2026