FDA 510(k)

Visalys Restorative Primer

Número K: K191523 · 2019-10-09

Data da decisão2019-10-09

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Visalys Restorative Primer is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K191523. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Visalys Restorative Primer?

Visalys Restorative Primer is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K191523.

When did Visalys Restorative Primer receive FDA 510(k) clearance?

Visalys Restorative Primer received FDA 510(k) clearance on 2019-10-09, under 510(k) number K191523.

Who is the listed applicant for Visalys Restorative Primer?

The FDA 510(k) record lists Kettenbach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visalys Restorative Primer?

The FDA product code for Visalys Restorative Primer is KLE.

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Outros registros que listam Kettenbach GmbH & Co. KG como candidato(a)

K262243Profisil Free K250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)K230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)K191527Visalys CemCore, Visalys Cem Core Try In Paste K191524Visalys Tooth Primer

Dispositivos Relacionados (Código: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

Fonte oficial

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