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FDA 510(k)

CLEARFIL Universal Bond Quick 2

K-Number: K231039 · 2023-12-13

ApplicantKuraray Noritake Dental, Inc.
Decision Date2023-12-13
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL Universal Bond Quick 2 is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2023-12-13 under approval number K231039. 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 CLEARFIL Universal Bond Quick 2?

CLEARFIL Universal Bond Quick 2 is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K231039.

When was CLEARFIL Universal Bond Quick 2 approved by the FDA?

CLEARFIL Universal Bond Quick 2 received FDA 510(k) clearance on 2023-12-13, under approval number K231039.

What company makes CLEARFIL Universal Bond Quick 2?

CLEARFIL Universal Bond Quick 2 is manufactured by Kuraray Noritake Dental, Inc..

What is the FDA product code for CLEARFIL Universal Bond Quick 2?

The FDA product code for CLEARFIL Universal Bond Quick 2 is KLE.

Other Devices by Kuraray Noritake Dental, Inc.

K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack K153476KATANA AVENCIA Block K170834CERABIEN ZR K170986KATANA Zirconia Block K191980CLEARFIL MAJESTY ES Flow K191133KATANA Cleaner, KATANA Cleaner (Trial)

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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

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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