3Shape Ortho System
K-Number: K152086 · 2016-04-28
Device Summary
Frequently Asked Questions
What is the 3Shape Ortho System?
3Shape Ortho System is a medical device that received FDA 510(k) clearance on 2016-04-28. The listed applicant is 3Shape A/S. The 510(k) number is K152086.
When did 3Shape Ortho System receive FDA 510(k) clearance?
3Shape Ortho System received FDA 510(k) clearance on 2016-04-28, under 510(k) number K152086.
Who is the listed applicant for 3Shape Ortho System?
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 Ortho System?
The FDA product code for 3Shape Ortho System is PNN.
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.
Related Devices (Code: PNN)
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.
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.