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FDA 510(k)

StoneBite and StoneBite scan

K-Number: K190571 · 2019-11-07

ApplicantDreve Dentamid GmbH
Decision Date2019-11-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

StoneBite and StoneBite scan is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K190571. 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 StoneBite and StoneBite scan?

StoneBite and StoneBite scan is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K190571.

When did StoneBite and StoneBite scan receive FDA 510(k) clearance?

StoneBite and StoneBite scan received FDA 510(k) clearance on 2019-11-07, under 510(k) number K190571.

Who is the listed applicant for StoneBite and StoneBite scan?

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

What is the FDA product code for StoneBite and StoneBite scan?

The FDA product code for StoneBite and StoneBite scan is ELW.

Other records listing Dreve Dentamid GmbH 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.

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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

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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