CamX Triton HD, Cam Spectra Proxi

GUDID E247J27001

DÜRR DENTAL SE

Dental caries detector, optical induced fluorescence

• Primary Device ID: E247J27001
• NIH Device Record Key: 1a15a231-0c1f-4c9c-9074-76bb34b0c61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CamX Triton HD, Cam Spectra Proxi
• Version Model Number: J2700
• Company DUNS: 315563684
• Company Name: DÜRR DENTAL SE
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247J27001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172007

FDA Product Code

• NTK: Caries Detector, Laser Light, Transmission

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: 2018-08-06
• Device Publish Date: 2018-07-06

Devices Manufactured by DÜRR DENTAL SE

• E24721301003290 - VistaPosition Anterior: 2026-03-23 Dental x-ray film holder.
• E24721301003300 - VistaPosition Posterior: 2026-03-23 Dental x-ray film holder.
• E24721301003320 - VistaPosition Endo: 2026-03-23 Dental x-ray film holder.
• E24721301003330 - VistaPosition Bitewing: 2026-03-23 Dental x-ray film holder.
• E2472110100003A20 - VistaSoft: 2025-09-30 Dental Imaging Software.
• E24721301004130 - VistaPosition Anterior: 2024-05-27
• E24721301004140 - VistaPosition Posterior: 2024-05-27
• E24721301004150 - VistaPosition Endo: 2024-05-27