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myray

FDA UDI

Class II (US FDA UDI)

by Cefla Societa' Cooperativa

Identity

Trade Name
myray FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
Digital panoramic, cephalometric and tomographic extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
Model / Reference
hyperion X5 (3D CEPH) FDA UDI
Description
Digital panoramic, cephalometric and tomographic extra-oral X-ray system. Cephalometric arm is optional. FDA UDI

Identifiers

Catalog Number
70BB0000 FDA UDI
Primary DI / UDI-DI
08033837932888 FDA UDI
510(k) Number
K200688 FDA UDI
FDA Product Code
MUH FDA UDI
OAS FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
892.1750 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

myray by Cefla Societa' Cooperativa — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cefla Societa' Cooperativa

Sources (1)

  • FDA UDI 120dbdd2-82d2-4800-b88b-99675468fd54 37 fields · synced May 30, 2026