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FDA 510(k)

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)

K-Number: K210473 · 2021-11-02

ApplicantImicryl Dis Malzemeleri Sanayi VE Ticaret AS
Decision Date2021-11-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is a medical device manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2021-11-02 under approval number K210473. 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 Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is a medical device that received FDA 510(k) clearance on 2021-11-02. It is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K210473.

When was Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) approved by the FDA?

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) received FDA 510(k) clearance on 2021-11-02, under approval number K210473.

What company makes Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS.

What is the FDA product code for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

The FDA product code for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is EMA.

Other Devices by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K192178R&D Series Nova Compo N K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose K213609NOVA RESIN dual cure, self adhesive resin cement K220077IMICRYL Composite, Composite Flow Materials

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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