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FDA 510(k)

DX. Bond V Dental Bonding Adhesive

K-Number: K232978 · 2023-09-22

ApplicantSino-Dentex Co., Ltd.
Decision Date2023-09-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DX. Bond V Dental Bonding Adhesive is a medical device manufactured by Sino-Dentex Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under approval number K232978. 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 DX. Bond V Dental Bonding Adhesive?

DX. Bond V Dental Bonding Adhesive is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Sino-Dentex Co., Ltd.. The 510(k) number is K232978.

When was DX. Bond V Dental Bonding Adhesive approved by the FDA?

DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance on 2023-09-22, under approval number K232978.

What company makes DX. Bond V Dental Bonding Adhesive?

DX. Bond V Dental Bonding Adhesive is manufactured by Sino-Dentex Co., Ltd..

What is the FDA product code for DX. Bond V Dental Bonding Adhesive?

The FDA product code for DX. Bond V Dental Bonding Adhesive is KLE.

Related Clinical Trials

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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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