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FDA 510(k)

DentMix VPS Impression Material

K-Number: K223892 · 2023-04-27

ApplicantInnovative Product Brands, Inc.
Decision Date2023-04-27
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DentMix VPS Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Product Brands, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K223892. 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 DentMix VPS Impression Material?

DentMix VPS Impression Material is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Innovative Product Brands, Inc.. The 510(k) number is K223892.

When did DentMix VPS Impression Material receive FDA 510(k) clearance?

DentMix VPS Impression Material received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223892.

Who is the listed applicant for DentMix VPS Impression Material?

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

What is the FDA product code for DentMix VPS Impression Material?

The FDA product code for DentMix VPS Impression Material is ELW.

Other records listing Innovative Product Brands, 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.

K220612PrimeLOC Attachment System

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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