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FDA 510(k)

CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER

K-Number: K930455 · 1993-04-08

ApplicantVoco GmbH
Decision Date1993-04-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K930455. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER?

CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Voco GmbH. The 510(k) number is K930455.

When did CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER receive FDA 510(k) clearance?

CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER received FDA 510(k) clearance on 1993-04-08, under 510(k) number K930455.

Who is the listed applicant for CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER?

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

What is the FDA product code for CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER?

The FDA product code for CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER is EMA.

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Related Devices (Code: EMA)

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K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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