Imagen Sensor BOOM IS038-DL

GUDID 08055060430443

DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS

TRIDENT SRL

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: 08055060430443
• NIH Device Record Key: dbac9845-f525-4533-9ef7-69298c6f5cf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imagen Sensor BOOM
• Version Model Number: Size 1
• Catalog Number: IS038-DL
• 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: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com
• Phone: 407 319-1348
• Email: marcelo@xrddental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055060430443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210312

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: 2022-03-10
• Device Publish Date: 2022-03-02

Devices Manufactured by TRIDENT SRL

• 08055060430948 - Intraoral Digital Impression Instrument: 2022-07-28 Intra oral scanner for digital impression of Dental restoration
• 08055060430955 - Intraoral Digital Impression Instrument: 2022-07-28 Intra oral scanner for digital impression of Dental restoration
• 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: 2022-03-10DIGITAL 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: 2020-09-25 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.