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FDA 510(k)

LITE ART

K-Number: K101621 · 2010-08-23

ApplicantShofu Dental Corp.
Decision Date2010-08-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LITE ART is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K101621. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITE ART?

LITE ART is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Shofu Dental Corp.. The 510(k) number is K101621.

When did LITE ART receive FDA 510(k) clearance?

LITE ART received FDA 510(k) clearance on 2010-08-23, under 510(k) number K101621.

Who is the listed applicant for LITE ART?

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

What is the FDA product code for LITE ART?

The FDA product code for LITE ART is EBF.

Other records listing Shofu Dental Corp. as applicant

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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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