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FDA 510(k)

R&D Series Nova Compo N

K-Number: K192178 · 2019-12-20

ApplicantImicryl Dis Malzemeleri Sanayi VE Ticaret AS
Decision Date2019-12-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R&D Series Nova Compo N is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192178. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R&D Series Nova Compo N?

R&D Series Nova Compo N is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K192178.

When did R&D Series Nova Compo N receive FDA 510(k) clearance?

R&D Series Nova Compo N received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192178.

Who is the listed applicant for R&D Series Nova Compo N?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D Series Nova Compo N?

The FDA product code for R&D Series Nova Compo N is EBF.

Other records listing Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220077IMICRYL Composite, Composite Flow MaterialsK213609NOVA RESIN dual cure, self adhesive resin cementK210473Nova 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

Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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