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)

Infinix Universal Composite

K-Number: K182921 · 2019-09-13

ApplicantNobio , Ltd.
Decision Date2019-09-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Infinix Universal Composite is the device name listed in this FDA 510(k) record. The listed applicant is Nobio , Ltd.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K182921. 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 Infinix Universal Composite?

Infinix Universal Composite is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Nobio , Ltd.. The 510(k) number is K182921.

When did Infinix Universal Composite receive FDA 510(k) clearance?

Infinix Universal Composite received FDA 510(k) clearance on 2019-09-13, under 510(k) number K182921.

Who is the listed applicant for Infinix Universal Composite?

The FDA 510(k) record lists Nobio , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinix Universal Composite?

The FDA product code for Infinix Universal Composite is EBF.

Other records listing Nobio , Ltd. 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.

K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeK183391Novidia Universal BondK182714Novidia Bulk Fill Flow CompositeK182580Novidia Flowable Composite

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

View on FDA Database →

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

↑