Cleared Traditional

K231696 - Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231696 · Prevest Denpro Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
60d
Days
Class 2
Risk

K231696 is an FDA 510(k) clearance for the Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on August 11, 2023 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prevest Denpro Limited devices

Submission Details

510(k) Number K231696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 417
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K231696.
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