Imagen Sensor BOOM IS038-DL

GUDID 08055060430443

DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS

TRIDENT SRL

Dental digital imaging sensor, intraoral
Primary Device ID08055060430443
NIH Device Record Keydbac9845-f525-4533-9ef7-69298c6f5cf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagen Sensor BOOM
Version Model NumberSize 1
Catalog NumberIS038-DL
Company DUNS430142798
Company NameTRIDENT SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com
Phone407 319-1348
Emailmarcelo@xrddental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108055060430443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-10
Device Publish Date2022-03-02

Devices Manufactured by TRIDENT SRL

08055060430948 - Intraoral Digital Impression Instrument2022-07-28 Intra oral scanner for digital impression of Dental restoration
08055060430955 - Intraoral Digital Impression Instrument2022-07-28 Intra oral scanner for digital impression of Dental restoration
08055060430429 - I-View Silver2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430436 - I-View Silver size 22022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430443 - Imagen Sensor BOOM2022-03-10DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430443 - Imagen Sensor BOOM2022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430450 - Imagen Sensor BOOM size 22022-03-10 DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
08055060430405 - Blu2020-09-25 Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
08055060430412 - Blu size 22020-09-25 Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

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