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PantOs 16 xp Ceph

FDA UDI

Class II (US FDA UDI)

by Bluo Electronics Srl

Identity

Trade Name
PantOs 16 xp Ceph FDA UDI
Generic Name
Stationary panoramic dental x-ray system, analogue FDA UDI
Device Name
Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items FDA UDI
Model / Reference
8468200500 FDA UDI
Description
Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items FDA UDI

Identifiers

Primary DI / UDI-DI
E31584682005000 FDA UDI
510(k) Number
K031801 FDA UDI
FDA Product Code
EHD FDA UDI
MQB FDA UDI
MUH FDA UDI
GMDN Term
Stationary panoramic dental x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
892.1680 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 dental x-ray system, analogue

PantOs 16 xp Ceph by Bluo Electronics Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary panoramic dental x-ray system, analogue.

Cleared under the same submission

K031801 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 bbfd0b73-d0fb-4d41-9c48-9809889047ee 36 fields · synced Jun 6, 2026