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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 intraoral dental x-ray system, digital FDA UDI
Device Name
X-ray unit designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. FDA UDI
Model / Reference
RX DC (extend) FDA UDI
Description
X-ray unit designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. FDA UDI

Identifiers

Catalog Number
MRXDCUS115 FDA UDI
Primary DI / UDI-DI
08033837930136 FDA UDI
510(k) Number
K080076 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

myray by Cefla Societa' Cooperativa — 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

K080076 also covers:

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 c8a28646-9892-43a0-95c7-fa1a78f6168a 37 fields · synced May 30, 2026