Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diapaste

K-Number: K190091 · 2020-03-27

Decision Date2020-03-27
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Diapaste is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-03-27 under approval number K190091. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diapaste?

Diapaste is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by DiaDent Group International. The 510(k) number is K190091.

When was Diapaste approved by the FDA?

Diapaste received FDA 510(k) clearance on 2020-03-27, under approval number K190091.

What company makes Diapaste?

Diapaste is manufactured by DiaDent Group International.

What is the FDA product code for Diapaste?

The FDA product code for Diapaste is KIF.

Other Devices by DiaDent Group International

View all 18 devices →

Related Devices (Code: KIF)

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.