Blu IS028-S

GUDID 08055060430405

Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

TRIDENT SRL

Dental digital imaging sensor, intraoral

Primary Device ID	08055060430405
NIH Device Record Key	5a971e00-8a03-42b7-90be-1d175f4096c0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Blu
Version Model Number	Size 1
Catalog Number	IS028-S
Company DUNS	430142798
Company Name	TRIDENT SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	(904) 477-3203
Email	joyce510kfda@gmail.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com
Phone	8005181102
Email	support@digi-doc.com

Device Dimensions

Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter
Width	25.4 Millimeter
Length	36.8 Millimeter
Height	4.8 Millimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055060430405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K200625

FDA Product Code

MUH	System, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-09-25
Device Publish Date	2020-09-17

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08055060430429 - I-View Silver	2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430436 - I-View Silver size 2	2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430443 - Imagen Sensor BOOM	2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430450 - Imagen Sensor BOOM size 2	2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430405 - Blu	2020-09-25Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
08055060430405 - Blu	2020-09-25 Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
08055060430412 - Blu size 2	2020-09-25 Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.