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FDA 510(k)

TAKE 1

K-Number: K091613 · 2009-10-07

ApplicantKerr Corp.
Decision Date2009-10-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAKE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corp.. It received FDA 510(k) clearance on 2009-10-07 under 510(k) number K091613. 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 TAKE 1?

TAKE 1 is a medical device that received FDA 510(k) clearance on 2009-10-07. The listed applicant is Kerr Corp.. The 510(k) number is K091613.

When did TAKE 1 receive FDA 510(k) clearance?

TAKE 1 received FDA 510(k) clearance on 2009-10-07, under 510(k) number K091613.

Who is the listed applicant for TAKE 1?

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

What is the FDA product code for TAKE 1?

The FDA product code for TAKE 1 is ELW.

Other records listing Kerr Corp. 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.

K090292PREMISE MODIFIEDK081695DMC COMPOSITEK072622STANDOUT 2K042888DEMETRON IDS CURING LIGHTK031484STAND OUTK014179DEMETRON LC

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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.

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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