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FDA 510(k)

1ST IMPRESSION

K-Number: K921571 · 1993-09-10

ApplicantWykle Research, Inc.
Decision Date1993-09-10
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

1ST IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Wykle Research, Inc.. It received FDA 510(k) clearance on 1993-09-10 under 510(k) number K921571. 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 1ST IMPRESSION?

1ST IMPRESSION is a medical device that received FDA 510(k) clearance on 1993-09-10. The listed applicant is Wykle Research, Inc.. The 510(k) number is K921571.

When did 1ST IMPRESSION receive FDA 510(k) clearance?

1ST IMPRESSION received FDA 510(k) clearance on 1993-09-10, under 510(k) number K921571.

Who is the listed applicant for 1ST IMPRESSION?

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

What is the FDA product code for 1ST IMPRESSION?

The FDA product code for 1ST IMPRESSION is ELW.

Related Clinical Trials

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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Other records listing Wykle Research, 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.

K952670CUPRALLOYK910632ACCU-MIX AMALGAMATOR

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-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.

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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