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FDA 510(k)

A-Silicone for Bite Registration

K-Number: K201684 · 2020-09-24

ApplicantShandong Huge Dental Material Corporation
Decision Date2020-09-24
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-Silicone for Bite Registration is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2020-09-24 under 510(k) number K201684. 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 A-Silicone for Bite Registration?

A-Silicone for Bite Registration is a medical device that received FDA 510(k) clearance on 2020-09-24. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K201684.

When did A-Silicone for Bite Registration receive FDA 510(k) clearance?

A-Silicone for Bite Registration received FDA 510(k) clearance on 2020-09-24, under 510(k) number K201684.

Who is the listed applicant for A-Silicone for Bite Registration?

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

What is the FDA product code for A-Silicone for Bite Registration?

The FDA product code for A-Silicone for Bite Registration is ELW.

Other records listing Shandong Huge Dental Material Corporation as applicant

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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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