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FDA 510(k)

tün® ultrasonic tips product family

K-Number: K182145 · 2019-06-07

Decision Date2019-06-07
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

tün® ultrasonic tips product family is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Endodontics. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K182145. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the tün® ultrasonic tips product family?

tün® ultrasonic tips product family is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Engineered Endodontics. The 510(k) number is K182145.

When did tün® ultrasonic tips product family receive FDA 510(k) clearance?

tün® ultrasonic tips product family received FDA 510(k) clearance on 2019-06-07, under 510(k) number K182145.

Who is the listed applicant for tün® ultrasonic tips product family?

The FDA 510(k) record lists Engineered Endodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for tün® ultrasonic tips product family?

The FDA product code for tün® ultrasonic tips product family is ELC.

Related Devices (Code: ELC)

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

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