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 a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2016-09-06 under approval 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. It is manufactured by 3Shape A/S. The 510(k) number is K151455.
When was 3Shape Abutment Designer Software approved by the FDA?
3Shape Abutment Designer Software received FDA 510(k) clearance on 2016-09-06, under approval number K151455.
What company makes 3Shape Abutment Designer Software?
3Shape Abutment Designer Software is manufactured by 3Shape A/S.
What is the FDA product code for 3Shape Abutment Designer Software?
The FDA product code for 3Shape Abutment Designer Software is PNP.
Other Devices by 3Shape A/S
Related Devices (Code: PNP)
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.