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FDA 510(k)

DEMI

K-Number: K071251 · 2007-07-26

ApplicantKerr Corporation
Decision Date2007-07-26
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEMI is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2007-07-26 under 510(k) number K071251. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMI?

DEMI is a medical device that received FDA 510(k) clearance on 2007-07-26. The listed applicant is Kerr Corporation. The 510(k) number is K071251.

When did DEMI receive FDA 510(k) clearance?

DEMI received FDA 510(k) clearance on 2007-07-26, under 510(k) number K071251.

Who is the listed applicant for DEMI?

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

What is the FDA product code for DEMI?

The FDA product code for DEMI is EBZ.

Related PubMed Literature

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Other records listing Kerr Corporation as applicant

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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