← Back to catalogue

X-MIND prime 3D

FDA UDI

Class II (US FDA UDI)

by De Götzen Srl

Identity

Trade Name
X-MIND prime 3D FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
X-MIND prime 3D wall version open range without WS and Monitor FDA UDI
Model / Reference
XMP 3D WALL 110-240V NO WS NO MONITOR FDA UDI
Description
X-MIND prime 3D wall version open range without WS and Monitor FDA UDI

Identifiers

Catalog Number
W1200015 FDA UDI
Primary DI / UDI-DI
D804W12000150 FDA UDI
510(k) Number
K201382 FDA UDI
FDA Product Code
OAS FDA UDI
MUH FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
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 panoramic/tomographic dental x-ray system, digital

X-MIND prime 3D by De Götzen Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary panoramic/tomographic dental x-ray system, digital.

Cleared under the same submission

K201382 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
De Götzen Srl

Sources (1)

  • FDA UDI 01b0f99c-d60a-42e5-a5aa-88e024f3a9e9 37 fields · synced May 30, 2026