FDA.reportPublic FDA data

CamX Proxi Interchangeable Head

Primary DI
E247J27131
Brand
CamX Proxi Interchangeable Head
Company
DÜRR DENTAL SE
Model
J2713
Published
2022-03-04
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
E247J27131PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

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
E24721301003290VistaPosition AnteriorRWT01.1D121301003292026-03-13
E24721301003300VistaPosition PosteriorRWT01.4D121301003302026-03-13
E24721301003320VistaPosition EndoRWT01.3D121301003322026-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
04262352350035DI ScanZetta25 AGNTK2025-02-21
10194665007928A-dec A-DEC, INC.NTK2025-02-11
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-12-03
00816063022213iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.NTK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.NTK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.NTK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022664iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
00858809006224Planmeca Emerald SD4D TECHNOLOGIES, LLCNTK2022-07-06
EKAV100270000DIAGNOdent pen 2190KaVo Dental GmbHNTK2022-04-15
00816063020691iTero Element 5D Plus cart configuration Align Technology, Inc.NTK2021-06-04
00816063020707iTero Element 5D Plus US cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020721iTero Element 5D Plus upgrade cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020745iTero Element 5D Plus mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020752iTero Element 5D Plus US mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020776iTero Element 5D Plus upgrade mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020783iTero Element 5D Plus US wand upgradeAlign Technology, Inc.NTK2021-06-04