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FDA 510(k)

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

K-Number: K201010 · 2020-08-14

ApplicantNobio , Ltd.
Decision Date2020-08-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is a medical device manufactured by Nobio , Ltd.. It received FDA 510(k) clearance on 2020-08-14 under approval number K201010. 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 Flowable Composite, Infinix Bulk Fill Flow Composite?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Nobio , Ltd.. The 510(k) number is K201010.

When was Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite approved by the FDA?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite received FDA 510(k) clearance on 2020-08-14, under approval number K201010.

What company makes Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is manufactured by Nobio , Ltd..

What is the FDA product code for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

The FDA product code for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is EBF.

Related Clinical Trials

NCT07261735 Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy RECRUITING NCT07535086 Clinical Performance of Short Fiber Reinforced Flowable Versus Conventional Injectable Flowable Resin Composite Restorations in Class I Carious Cavities ACTIVE_NOT_RECRUITING

Other Devices by Nobio , Ltd.

K183391Novidia Universal Bond K182921Infinix Universal Composite K182714Novidia Bulk Fill Flow Composite K182580Novidia Flowable Composite

Related Devices (Code: EBF)

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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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