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510(k) K200100

Device
Abutment Design
Applicant
3Shape A/S
510(k) number
K200100
Product code
PNP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-07
Date received
2020-01-16
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
Jenny Axel
Address
Holmens Kanal 7 Copenhagen DK 1060 1060

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
K193352AbutmentCADExocad GmbH2021-07-21
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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