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FDA 510(k)

Visalys CemCore, Visalys Cem Core Try In Paste

K-Number: K191527 · 2019-11-08

ApplicantKettenbach GmbH & Co. KG
Decision Date2019-11-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Visalys CemCore, Visalys Cem Core Try In Paste is a medical device manufactured by Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2019-11-08 under approval number K191527. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visalys CemCore, Visalys Cem Core Try In Paste?

Visalys CemCore, Visalys Cem Core Try In Paste is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Kettenbach GmbH & Co. KG. The 510(k) number is K191527.

When was Visalys CemCore, Visalys Cem Core Try In Paste approved by the FDA?

Visalys CemCore, Visalys Cem Core Try In Paste received FDA 510(k) clearance on 2019-11-08, under approval number K191527.

What company makes Visalys CemCore, Visalys Cem Core Try In Paste?

Visalys CemCore, Visalys Cem Core Try In Paste is manufactured by Kettenbach GmbH & Co. KG.

What is the FDA product code for Visalys CemCore, Visalys Cem Core Try In Paste?

The FDA product code for Visalys CemCore, Visalys Cem Core Try In Paste is EMA.

Other Devices by Kettenbach GmbH & Co. KG

K191523Visalys Restorative Primer 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: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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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