FDA.reportPublic FDA data

CamX Triton HD, Cam Spectra

Primary DI
E247J25001
Brand
CamX Triton HD, Cam Spectra
Company
DÜRR DENTAL SE
Model
J2500
Published
2018-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NTKCaries Detector, Laser Light, Transmission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTKCaries Detector, Laser Light, TransmissionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172007000CamX Triton HD Proxi HeadDuerr Dental AG2017-11-22NTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E247J25001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, optical induced fluorescenceA mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315563684
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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E24721301003330VistaPosition BitewingRWT01.2D121301003332026-03-13
E24721301004130VistaPosition AnteriorRWT01.A121301004132024-05-17
E24721301004140VistaPosition PosteriorRWT01.4A121301004132024-05-17
E24721301004150VistaPosition EndoRWT01.3A121301004152024-05-17
E24721301004160VistaPosition BitewingRWT01.2A12024-05-17
E2472110100003A20VistaSoft2110100003Version 4.0.x2025-09-22
E247A7000580511HVE Air Protect XL Plus, gray (4 pcs)A7000580512021-11-02
E247A7000580611HVE Air Protect XL Plus, gray (1 pcs)A7000580612021-11-02
E247A7000590111HVE Air Protect XL, gray (20 pcs)A7000590112021-11-02
E247A7000590511HVE Air Protect XL, gray (5 pcs)A7000590512021-11-02
E247E7300VisionXE7300Version 4.0.x2019-12-05
E247E72000DBSWIN 5.11.0E72002016-09-21
E247E7200A0DBSWINE7200A2019-04-09
E247G36110Phosphor Storage Plate IDX S1G36112021-09-19
E247G36120Phosphor Storage Plate IDX S2G36122021-09-19
E247G36130Phosphor Storage Plate IDX S3G36132021-09-19
E247G36140Phosphor Storage Plate IDX S4G36142021-09-19

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Primary DI, Brand, Company table
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E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
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10194665007928A-dec A-DEC, INC.NTK2025-02-11
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00816063022213iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
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