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FDA 510(k)

LeEject 2 Dental Syringe and Needle System

K-Number: K171254 · 2017-11-16

ApplicantAdvanced Technology and Capital, Inc.
Decision Date2017-11-16
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LeEject 2 Dental Syringe and Needle System is a medical device manufactured by Advanced Technology and Capital, Inc.. It received FDA 510(k) clearance on 2017-11-16 under approval number K171254. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LeEject 2 Dental Syringe and Needle System?

LeEject 2 Dental Syringe and Needle System is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Advanced Technology and Capital, Inc.. The 510(k) number is K171254.

When was LeEject 2 Dental Syringe and Needle System approved by the FDA?

LeEject 2 Dental Syringe and Needle System received FDA 510(k) clearance on 2017-11-16, under approval number K171254.

What company makes LeEject 2 Dental Syringe and Needle System?

LeEject 2 Dental Syringe and Needle System is manufactured by Advanced Technology and Capital, Inc..

What is the FDA product code for LeEject 2 Dental Syringe and Needle System?

The FDA product code for LeEject 2 Dental Syringe and Needle System is EJI.

Related Clinical Trials

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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.

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