FDA.reportPublic FDA data

Dental CAD/CAM system, chairside

Definition
An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.
GUDID devices
249
Last updated
2021-12-27 10:05:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860007842900Tupel 3DTUPEL LTDDesktop 3D Dental Scanner2021-12-17
08800026700074i700 Reusable tipMedit Corp.MD-RT02002021-11-16
08800026700081i500 Reusable tipMedit Corp.MD-RT01002021-11-16
08800026700050i700 Single use tipMedit Corp.MD-ST02002021-11-15
08800026700067i700 WirelessMedit Corp.MD-IS03002021-11-15
04260521363022ChairsideCADexocad GmbH3.0 Galway2021-10-26
04260521363305Ceramill Mind DRSexocad GmbH1.02021-10-26
D040706751VeriPulse IOSWHIP-MIX CORPORATION706752021-06-07
D040792751VeriPulse IOSWHIP-MIX CORPORATION792752021-06-07
00816063020677iTero Articulator KitAlign Technology, Inc.1078062021-06-04
00816063020684iTero Element 2 Plus, cart configurationAlign Technology, Inc.2114832021-06-04
00816063020691iTero Element 5D Plus cart configuration Align Technology, Inc.2114842021-06-04
00816063020707iTero Element 5D Plus US cart configurationAlign Technology, Inc.2114852021-06-04
00816063020714iTero Element 2 Plus upgrade cart configurationAlign Technology, Inc.2113762021-06-04
00816063020721iTero Element 5D Plus upgrade cart configurationAlign Technology, Inc.2115722021-06-04
00816063020738iTero Element 2 Plus mobile configurationAlign Technology, Inc.2114902021-06-04
00816063020745iTero Element 5D Plus mobile configurationAlign Technology, Inc.2114912021-06-04
00816063020752iTero Element 5D Plus US mobile configurationAlign Technology, Inc.2114922021-06-04
00816063020769iTero Element 2 Plus upgrade mobile configurationAlign Technology, Inc.2113722021-06-04
00816063020776iTero Element 5D Plus upgrade mobile configurationAlign Technology, Inc.2115732021-06-04
00816063020783iTero Element 5D Plus US wand upgradeAlign Technology, Inc.2113782021-06-04
00816063020790iTero Element 5D Plus wand upgradeAlign Technology, Inc.2113772021-06-04
00816063020806iTero Element 5D Plus Ready US Cart configurationAlign Technology, Inc.2118982021-06-04
00816063020813iTero Element 5D Plus Ready US Mobile configurationAlign Technology, Inc.2118992021-06-04
00816063020820iTero Wheel standAlign Technology, Inc.2113842021-06-04
00816063020837iTero Computing UnitAlign Technology, Inc.2113852021-06-04
00816063020844iTero Mobile Computing UnitAlign Technology, Inc.2113862021-06-04
00816063020851iTero Element Scanning UnitAlign Technology, Inc.2117822021-06-04
00816063020868iTero 5D Scanning UnitAlign Technology, Inc.2117832021-06-04
00816063020875iTero 5D Scanning UnitAlign Technology, Inc.2118712021-06-04
00816063020981iTero Element Plus wheel stand, serviceAlign Technology, Inc.2115632021-06-04
00816063020998Packed Element Plus Scanning Unit, RMAAlign Technology, Inc.2118892021-06-04
00816063021001Packed 5D Plus Scanning Unit, RMAAlign Technology, Inc.2122602021-06-04
00816063021018Packed 5D Plus US Scanning Unit, RMAAlign Technology, Inc.2122612021-06-04
00816063021025Packed 5D Plus Lite Scanning Unit, RMAAlign Technology, Inc.2122032021-06-04
00816063021032Packed iTero Computing Unit RMA E2 PlusAlign Technology, Inc.2098652021-06-04
00816063021049Packed iTero Computing Unit RMA 5D PlusAlign Technology, Inc.2122652021-06-04
00816063021056Packed iTero Mobile Computing Unit RMA E2 PlusAlign Technology, Inc.2098752021-06-04
00816063021063Packed iTero Mobile Computing Unit RMA 5D PlusAlign Technology, Inc.2122662021-06-04
00816063021070DOA Kit, Element 2 PlusAlign Technology, Inc.2117892021-06-04
00816063021087DOA Kit, 5D PlusAlign Technology, Inc.2122692021-06-04
00816063021094DOA Kit, 5D US PlusAlign Technology, Inc.2122702021-06-04
00816063021100DOA Kit, Element 5D Plus LiteAlign Technology, Inc.2122022021-06-04
00860006572501Gro3X DIUGro3x, Inc.DIU-3D-71-0012021-05-20
08800026700043i700Medit Corp.MD-IS02002021-02-25
60192155943065CS 3800 WirelessCARESTREAM DENTAL LLC59430632021-01-11
E27667188570CERECSIRONA Dental Systems GmbH67188572020-11-30
05902729753562PrograScan One3shape Trios A/SS1P-2 2020-11-26
05902729753609PrograScan One3shape Trios A/SS1-2 2020-11-26
08800026700012MeditMedit Corp.i5002018-02-28
00816063020493iTero Element 5DAlign Technology, Inc.2059292020-06-04
00816063020509iTero Element 5D Laptop ConfigurationAlign Technology, Inc.2061602020-06-04
00816063020561iTero Element 5D Upgrade kitAlign Technology, Inc.2068552020-06-04
00816063020578iTero Element 5D Upgrade kit Laptop ConfigurationAlign Technology, Inc.2068562020-06-04
00816063020585iTero Element Scanner Sleeve (25pcs/Box)Align Technology, Inc.1092362020-06-04
00816063020608iTero Element Barrier SleevesAlign Technology, Inc.2091742020-06-04
00816063020615iTero Element 5D SleevesAlign Technology, Inc.2042842020-06-04
00816063020622iTero Element 5D US Laptop ConfigurationAlign Technology, Inc.2091552020-06-04
00816063020639iTero Element 5D US SystemAlign Technology, Inc.2091562020-06-04
00816063020646iTero Element 5D LC Upgrade, Kit USAlign Technology, Inc.2091572020-06-04
00816063020653iTero Element 5D upgrade, Kit USAlign Technology, Inc.2091762020-06-04
00841709112027Midmark True Definition ScannerMIDMARK CORPORATION70-2014-0340-22019-07-23
00841709112034Midmark True Definition ScannerMIDMARK CORPORATION78-8150-2258-32019-07-24
00841709112041Midmark True Definition ScannerMIDMARK CORPORATION41-0001-6049-32019-07-23
E23521570Shofu Block HCSHOFU DENTAL CORPORATION21572016-09-23
E2352157B9Shofu Block HCSHOFU DENTAL CORPORATION2157B2016-09-23
E23521580Shofu Block HCSHOFU DENTAL CORPORATION21582016-09-23
E2352158B9Shofu Block HCSHOFU DENTAL CORPORATION2158B2016-09-23
E23521590Shofu Block HCSHOFU DENTAL CORPORATION21592016-09-23
E2352159B9Shofu Block HCSHOFU DENTAL CORPORATION2159B2016-09-23
E2352160B9Shofu Block HCSHOFU DENTAL CORPORATION2160B2016-09-23
E2352161B9Shofu Block HCSHOFU DENTAL CORPORATION2161B2016-09-23
E23521620Shofu Block HCSHOFU DENTAL CORPORATION21622016-09-23
E2352162B9Shofu Block HCSHOFU DENTAL CORPORATION2162B2016-09-23
E2352168B9Shofu Block HCSHOFU DENTAL CORPORATION2168B2016-09-23
E2352169B9Shofu Block HCSHOFU DENTAL CORPORATION2169B2016-09-23
E23521700Shofu Block HCSHOFU DENTAL CORPORATION21702016-09-23
E2352170B9Shofu Block HCSHOFU DENTAL CORPORATION2170B2016-09-23
E2352171B9Shofu Block HCSHOFU DENTAL CORPORATION2171B2016-09-23
E2352172B9Shofu Block HCSHOFU DENTAL CORPORATION2172B2016-09-23