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FDA 510(k)

CharmFlex

K-Number: K152766 · 2016-03-08

ApplicantDentkist, Inc.
Decision Date2016-03-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CharmFlex is the device name listed in this FDA 510(k) record. The listed applicant is Dentkist, Inc.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152766. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CharmFlex?

CharmFlex is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Dentkist, Inc.. The 510(k) number is K152766.

When did CharmFlex receive FDA 510(k) clearance?

CharmFlex received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152766.

Who is the listed applicant for CharmFlex?

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

What is the FDA product code for CharmFlex?

The FDA product code for CharmFlex is ELW.

Other records listing Dentkist, Inc. 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.

K193496CharmFil

Related Devices (Code: ELW)

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.

K254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorDent4you AGK233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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