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IntraOs 70

FDA UDI

Class II (US FDA UDI)

by Bluo Electronics Srl

Identity

Trade Name
IntraOs 70 FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
Intraoral X-ray unit (70 kV, 7 mA), sensor not included FDA UDI
Model / Reference
9320201300 FDA UDI
Description
Intraoral X-ray unit (70 kV, 7 mA), sensor not included FDA UDI

Identifiers

Primary DI / UDI-DI
E31593202013000 FDA UDI
510(k) Number
K031118 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, digitalMobile intraoral dental x-ray system, digitalStationary intraoral dental x-ray system, analogueMobile intraoral dental x-ray system, analogue

IntraOs 70 by Bluo Electronics Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile intraoral dental x-ray system, analogue.

Cleared under the same submission

K031118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bluo Electronics Srl

Sources (1)

  • FDA UDI ce09d0ca-df6f-46be-b9b3-e3710d0b8675 36 fields · synced May 30, 2026