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FDA 510(k)

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose

K-Number: K192913 · 2021-01-19

ApplicantImicryl Dis Malzemeleri Sanayi VE Ticaret AS
Decision Date2021-01-19
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is a medical device manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2021-01-19 under approval number K192913. 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 R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is a medical device that received FDA 510(k) clearance on 2021-01-19. It is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K192913.

When was R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose approved by the FDA?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose received FDA 510(k) clearance on 2021-01-19, under approval number K192913.

What company makes R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is manufactured by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS.

What is the FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

The FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is KLE.

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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) K213609NOVA RESIN dual cure, self adhesive resin cement K220077IMICRYL Composite, Composite Flow Materials

Related Devices (Code: KLE)

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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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