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Preva, 76" Reach, Deutsch

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
PREVA, 76" REACH, DEUTSCH FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
Intraoral X-ray with Handswitch FDA UDI
Model / Reference
PE7017-D FDA UDI
Description
Intraoral X-ray with Handswitch FDA UDI

Identifiers

Catalog Number
PE7017-D FDA UDI
Primary DI / UDI-DI
00841709103452 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

Preva, 76" Reach, Deutsch 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 b48dcfa8-564a-4ff9-a4ba-9b1037b879cf 37 fields · synced Jun 8, 2026