FDA 510(k)

Novidia Universal Bond

K-Number: K183391 · 2019-09-24

Decision Date2019-09-24

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Novidia Universal Bond is a medical device manufactured by Nobio , Ltd.. It received FDA 510(k) clearance on 2019-09-24 under approval number K183391. 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 Novidia Universal Bond?

Novidia Universal Bond is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Nobio , Ltd.. The 510(k) number is K183391.

When was Novidia Universal Bond approved by the FDA?

Novidia Universal Bond received FDA 510(k) clearance on 2019-09-24, under approval number K183391.

What company makes Novidia Universal Bond?

Novidia Universal Bond is manufactured by Nobio , Ltd..

What is the FDA product code for Novidia Universal Bond?

The FDA product code for Novidia Universal Bond is KLE.

Other Devices by Nobio , Ltd.

K182921Infinix Universal Composite K182714Novidia Bulk Fill Flow Composite K182580Novidia Flowable Composite K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

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.