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FDA 510(k)

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

K-Number: K231696 · 2023-08-11

ApplicantPrevest Denpro Limited
Decision Date2023-08-11
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is a medical device manufactured by Prevest Denpro Limited. It received FDA 510(k) clearance on 2023-08-11 under approval number K231696. 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 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Prevest Denpro Limited. The 510(k) number is K231696.

When was Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal approved by the FDA?

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal received FDA 510(k) clearance on 2023-08-11, under approval number K231696.

What company makes Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is manufactured by Prevest Denpro Limited.

What is the FDA product code for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

The FDA product code for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is KLE.

Related Clinical Trials

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Other Devices by Prevest Denpro Limited

K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) K233273C&B Ceramic; C&B Permanent; C&B Interim K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

View all 7 devices →

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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