Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2021-11-02 under 510(k) 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. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K210473.

When did Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) receive FDA 510(k) clearance?

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 510(k) number K210473.

Who is the listed applicant for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

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 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 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 cementK192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseK192178R&D Series Nova Compo N

Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.

↑