Model: SOTA Cloud Smart Sensor
DI: 00860013687601
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
99d8f92b-289e-42b9-b7ab-7ee9e28b2aeb
Distribution Status:
In Commercial Distribution
DUNS Number:
118275757
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860013687601
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 42297
Name: Stationary intraoral dental x-ray system, digital
Definition:
A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.
FDA Product Codes
MUH
System, X-Ray, Extraoral Source, Digital
Premarket Submissions
Submission Number:
K251793
Supplement Number:
000