Cleared Traditional

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

K231696 · Prevest Denpro Limited · Dental
Aug 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K231696 is an FDA 510(k) clearance for the Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on August 11, 2023, 60 days after receiving the submission on June 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K231696 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2023
Decision Date August 11, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200

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