Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Visalys Restorative Primer

K-Number: K191523 · 2019-10-09

ApplicantKettenbach GmbH & Co. KG
Decision Date2019-10-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Visalys Restorative Primer is a medical device manufactured by Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-09 under approval number K191523. 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 Restorative Primer?

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

When was Visalys Restorative Primer approved by the FDA?

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

What company makes Visalys Restorative Primer?

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

What is the FDA product code for Visalys Restorative Primer?

The FDA product code for Visalys Restorative Primer is KLE.

Other Devices by Kettenbach GmbH & Co. KG

K191527Visalys CemCore, Visalys Cem Core Try In Paste K191524Visalys Tooth 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.

↑