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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 the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology and Capital, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) 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. The listed applicant is Advanced Technology and Capital, Inc.. The 510(k) number is K171254.

When did LeEject 2 Dental Syringe and Needle System receive FDA 510(k) clearance?

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

Who is the listed applicant for LeEject 2 Dental Syringe and Needle System?

The FDA 510(k) record lists Advanced Technology and Capital, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07498621Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth ExtractionCOMPLETEDNCT07548892Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in ChildrenNOT_YET_RECRUITINGNCT07581249This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary TeethCOMPLETED

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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