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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 a medical device manufactured by Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2019-09-29 under approval 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. It is manufactured by Kettenbach GmbH & Co. KG. The 510(k) number is K191524.

When was Visalys Tooth Primer approved by the FDA?

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

What company makes Visalys Tooth Primer?

Visalys Tooth Primer is manufactured by Kettenbach GmbH & Co. KG.

What is the FDA product code for Visalys Tooth Primer?

The FDA product code for Visalys Tooth Primer is KLE.

Other Devices by Kettenbach GmbH & Co. KG

K191527Visalys CemCore, Visalys Cem Core Try In Paste K191523Visalys Restorative Primer 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) 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)

Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

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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