FDA 510(k)

NAVI ROOT

K-Number: K083901 · 2009-04-15

Decision Date2009-04-15

Product CodeLQY

DecisionSubstantially Equivalent

Device Summary

NAVI ROOT is the device name listed in this FDA 510(k) record. The listed applicant is S-Denti Co., Ltd.. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K083901. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVI ROOT?

NAVI ROOT is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is S-Denti Co., Ltd.. The 510(k) number is K083901.

When did NAVI ROOT receive FDA 510(k) clearance?

NAVI ROOT received FDA 510(k) clearance on 2009-04-15, under 510(k) number K083901.

Who is the listed applicant for NAVI ROOT?

The FDA 510(k) record lists S-Denti Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVI ROOT?

The FDA product code for NAVI ROOT is LQY.

Other records listing S-Denti Co., Ltd. as applicant

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.

K112508I-ROOT 100 K112153IROOT 100 MINI K100450I-ROOT

Related Devices (Code: LQY)

K252224Apex Locator (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242383Apex LocatorShenzhen Rogin Medical Co., Ltd.K242765Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Apex LocatorCefla S.C.K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd.K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd.

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.