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FDA 510(k)

Visalys Tooth Primer

K-Number: K191524 · 2019-09-29

ApplicantKettenbach GmbH & Co. KG
Decision Date2019-09-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Visalys Tooth 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 2019-09-29 under 510(k) number K191524. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visalys Tooth Primer?

Visalys Tooth Primer is a medical device that received FDA 510(k) clearance on 2019-09-29. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K191524.

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

Visalys Tooth Primer received FDA 510(k) clearance on 2019-09-29, under 510(k) number K191524.

Who is the listed applicant for Visalys Tooth 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 Tooth Primer?

The FDA product code for Visalys Tooth Primer is KLE.

Other records listing Kettenbach GmbH & Co. KG 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.

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 PasteK191523Visalys Restorative Primer

Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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