FDA.reportPublic FDA data

510(k) K043068

Device
DIFOTI USB 2.0 SYSTEM
Applicant
ELECTRO-OPTICAL SCIENCES, INC.
510(k) number
K043068
Product code
NTK  
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-29
Date received
2004-11-08
Regulation
872.1745
Classification name
Caries Detector, Laser Light, Transmission
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL GREENEBAUM
Address
1 Bridge St. Suite 15 Irvington NY US 10533 10533

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250771Primescan 2Dentsply Sirona, Inc.2025-08-29
K240573iTero Lumina™ ProAlign Technology , Ltd.2024-08-16
K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC2022-04-29
K193659iTero Element 5DAlign Technology, Inc.2020-03-20
K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH2019-11-23
K172007CamX Triton HD Proxi HeadDuerr Dental AG2017-11-22
K123402DIAGNOCAMKaltenbach & Voigt GmbH2013-09-24
K071429TI2200 TRANSILLUMINATION CABLEKerr Corporation2007-09-10
K062961MICROLUX TRANSILLUMINATORAddent, Inc.2007-02-08
K060080DIAGNODENT 2190 WITH PERIODONTAL PROBEKavo Dental Corporation2006-02-08

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases