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FDA 510(k)

3Shape Abutment Designer Software

K-Number: K151455 · 2016-09-06

Applicant3Shape A/S
Decision Date2016-09-06
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Shape Abutment Designer Software 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 2016-09-06 under 510(k) number K151455. 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 3Shape Abutment Designer Software?

3Shape Abutment Designer Software is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is 3Shape A/S. The 510(k) number is K151455.

When did 3Shape Abutment Designer Software receive FDA 510(k) clearance?

3Shape Abutment Designer Software received FDA 510(k) clearance on 2016-09-06, under 510(k) number K151455.

Who is the listed applicant for 3Shape Abutment Designer Software?

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 3Shape Abutment Designer Software?

The FDA product code for 3Shape Abutment Designer Software 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.

K200100Abutment DesignK1919113Shape Splint DesignK180941Ortho SystemK171634Ortho SystemK163677Ortho SystemK161884Ortho System

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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 GmbHK200100Abutment Design3Shape A/SK200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona

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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