Cleared Traditional

Harvest Dental HD Gum Strip (K231389) - FDA 510(k) Clearance

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

K231389 · Harvest Dental Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
96d
Days
Class 2
Risk

K231389 is an FDA 510(k) clearance for the Harvest Dental HD Gum Strip. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Harvest Dental Products, LLC (Brea, US). The FDA issued a Cleared decision on August 16, 2023 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Harvest Dental Products, LLC devices

Submission Details

510(k) Number K231389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date August 16, 2023
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 111
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K231389.
NextDent Base
K231388 · Vertex-Dental B.V. · Oct 2023
Lucitone Digital Print Denture System
K231578 · Dentsply Sirona · Oct 2023
Polibond
K232691 · Zirkonzahn Srl · Sep 2023
OnX Tough
K230445 · Sprintray, Inc. · Jul 2023
DD medical polymers (PMMA)
K230410 · Dental Direkt GmbH · Jun 2023
Harvest Printable Resin
K222489 · Harvest Dental Products, LLC · May 2023