Cleared Traditional

K222489 - Harvest Printable Resin

K222489 is an FDA 510(k) clearance for Harvest Printable Resin, manufactured by Harvest Dental Products, LLC. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K222489 · Harvest Dental Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
268d
Days
Class 2
Risk

K222489 is an FDA 510(k) clearance for the Harvest Printable Resin. 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 May 12, 2023 after a review of 268 days - an extended review cycle.

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

FDA 510(k) Submission Details - K222489

510(k) Number K222489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2022
Decision Date May 12, 2023
Days to Decision 268 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
141d slower than avg
Panel avg: 127d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 157
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K222489.
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Trusana™
K230098 · Myerson, LLC · Apr 2023
ACRIFIX
K230341 · Deltamed GmbH · Apr 2023
Denture Base Resin
K230115 · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 2023