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FDA 510(k)

NOVA RESIN dual cure, self adhesive resin cement

K-Number: K213609 · 2022-08-09

ApplicantImicryl Dis Malzemeleri Sanayi VE Ticaret AS
Decision Date2022-08-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOVA RESIN dual cure, self adhesive resin cement is a medical device manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2022-08-09 under approval number K213609. 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 RESIN dual cure, self adhesive resin cement?

NOVA RESIN dual cure, self adhesive resin cement is a medical device that received FDA 510(k) clearance on 2022-08-09. It is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K213609.

When was NOVA RESIN dual cure, self adhesive resin cement approved by the FDA?

NOVA RESIN dual cure, self adhesive resin cement received FDA 510(k) clearance on 2022-08-09, under approval number K213609.

What company makes NOVA RESIN dual cure, self adhesive resin cement?

NOVA RESIN dual cure, self adhesive resin cement is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS.

What is the FDA product code for NOVA RESIN dual cure, self adhesive resin cement?

The FDA product code for NOVA RESIN dual cure, self adhesive resin cement is EMA.

Related Clinical Trials

NCT07552350 Bioactive Restorative Materials for Class II Restorations ACTIVE_NOT_RECRUITING NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K192178R&D Series Nova Compo N K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose 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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