Model: 1.013.9712
DI: D090101397120
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:
710c3f7a-f9b7-4594-97d9-3e4c6278d36d
Distribution Status:
In Commercial Distribution
DUNS Number:
800111106
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D090101397120
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 44905
Name: Dental digital imaging sensor, intraoral
Definition:
An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.
FDA Product Codes
MUH
System, X-Ray, Extraoral Source, Digital
Premarket Submissions
Submission Number:
K172918
Supplement Number:
000