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)

TEETHAN 2.0

K-Number: K161716 · 2016-12-21

ApplicantBts S.P.A.
Decision Date2016-12-21
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TEETHAN 2.0 is a medical device manufactured by Bts S.P.A.. It received FDA 510(k) clearance on 2016-12-21 under approval number K161716. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEETHAN 2.0?

TEETHAN 2.0 is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Bts S.P.A.. The 510(k) number is K161716.

When was TEETHAN 2.0 approved by the FDA?

TEETHAN 2.0 received FDA 510(k) clearance on 2016-12-21, under approval number K161716.

What company makes TEETHAN 2.0?

TEETHAN 2.0 is manufactured by Bts S.P.A..

What is the FDA product code for TEETHAN 2.0?

The FDA product code for TEETHAN 2.0 is KZM.

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.

↑