FDA.reportPublic FDA data

510(k) K122065

Device
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
Applicant
ORMCO CORP.
510(k) number
K122065
Product code
NOF  
Decision
Substantially Equivalent (SESE)
Decision date
2013-02-08
Date received
2012-07-13
Regulation
872.3661
Classification name
System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wendy Garman
Address
1717 W. Collins Ave. Orange CA US 92867 92867

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141611LYTHOS DIGITAL IMPRESSION SYSTEMOrmco Corp.2014-12-05
K1224673M TRUE DEFINITION SCANNER3M Company2012-11-20
K0819613M UNITEK LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies2008-09-05
K0731993M ESPE LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies2007-12-21

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