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FDA 510(k)

IROOT 100 MINI

K-Number: K112153 · 2012-04-26

ApplicantS-Denti Co., Ltd.
Decision Date2012-04-26
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

IROOT 100 MINI 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 2012-04-26 under 510(k) number K112153. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IROOT 100 MINI?

IROOT 100 MINI is a medical device that received FDA 510(k) clearance on 2012-04-26. The listed applicant is S-Denti Co., Ltd.. The 510(k) number is K112153.

When did IROOT 100 MINI receive FDA 510(k) clearance?

IROOT 100 MINI received FDA 510(k) clearance on 2012-04-26, under 510(k) number K112153.

Who is the listed applicant for IROOT 100 MINI?

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 IROOT 100 MINI?

The FDA product code for IROOT 100 MINI is LQY.

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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 100K100450I-ROOTK083901NAVI ROOT

Related Devices (Code: LQY)

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.

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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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