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FDA 510(k)

Abutment Design

K-Number: K200100 · 2020-10-07

Applicant3Shape A/S
Decision Date2020-10-07
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Abutment Design is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200100. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Abutment Design?

Abutment Design is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is 3Shape A/S. The 510(k) number is K200100.

When did Abutment Design receive FDA 510(k) clearance?

Abutment Design received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200100.

Who is the listed applicant for Abutment Design?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Abutment Design?

The FDA product code for Abutment Design is PNP.

Other records listing 3Shape A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K1919113Shape Splint DesignK180941Ortho SystemK171634Ortho SystemK163677Ortho SystemK161884Ortho SystemK1514553Shape Abutment Designer Software

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Related Devices (Code: PNP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AGK231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.K221107TRUSTRgorithm KoreaK193352AbutmentCADExocad GmbHK200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply SironaK181932DTX Studio designNobel Biocare AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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