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Control Unit Asm., Preva 2.0 Ral 9010

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
CONTROL UNIT ASM.,PREVA 2.0 RAL 9010 FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
X-ray Control, w/ USB Hub, White FDA UDI
Model / Reference
30-A1065 FDA UDI
Description
X-ray Control, w/ USB Hub, White FDA UDI

Identifiers

Catalog Number
30-A1065 FDA UDI
Primary DI / UDI-DI
00841709103681 FDA UDI
510(k) Number
K043092 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary 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: Stationary intraoral dental x-ray system, digital

Control Unit Asm., Preva 2.0 Ral 9010 by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

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 def95802-b2c0-438e-91f7-e6b6bf77b5ce 37 fields · synced Jun 8, 2026