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Cliosoft

FDA UDI

Class II (US FDA UDI)

by Sota Precision Optics, Inc.

Identity

Trade Name
Cliosoft FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Model / Reference
Version 2 FDA UDI

Identifiers

Primary DI / UDI-DI
00851159007026 FDA UDI
510(k) Number
K110886 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary intraoral dental x-ray system, digital

Cliosoft by Sota Precision Optics, Inc. — 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

K110886 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sota Precision Optics, Inc.

Sources (1)

  • FDA UDI cb01e74b-a7fc-4dac-bb9a-56cb3ce31630 34 fields · synced May 30, 2026