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510(k) K193352

Device
AbutmentCAD
Applicant
Exocad GmbH
510(k) number
K193352
Product code
PNP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-21
Date received
2019-12-04
Regulation
872.3630
Classification name
Dental Abutment Design Software For Dental Laboratory
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefan Walter
Address
37, Julius-Reiber-Str. Darmstadt DE 64293 64293

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG2024-12-26
K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.2024-03-14
K221107TRUSTRgorithm Korea2023-07-18
K200100Abutment Design3Shape A/S2020-10-07
K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona2020-08-19
K181932DTX Studio designNobel Biocare AB2019-03-01
K1514553Shape Abutment Designer Software3Shape A/S2016-09-06

Legacy Summary#

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FDA Review#

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