Cleared Traditional

K180578 - Harvest Dental Polymer Blocks (FDA 510(k) Clearance)

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

K180578 · Harvest Dental Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
282d
Days
Class 2
Risk

K180578 is an FDA 510(k) clearance for the Harvest Dental Polymer Blocks. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Harvest Dental Products, LLC (Brea, US). The FDA issued a Cleared decision on December 12, 2018 after a review of 282 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 K180578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date December 12, 2018
Days to Decision 282 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
155d slower than avg
Panel avg: 127d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 188
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K180578.
Dura-Arch
K261261 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
“FLNT Base” and “FLNT Temp”
K253380 · Liaoning Upcera Co., Ltd. · Mar 2026
TempFIT Temporary Crown and Bridge Resin
K251271 · Rizhao Huge Biomaterials Company, Ltd. · Jun 2025
DentaTOOTH
K243370 · Asiga Pty, Ltd. · May 2025
Evoblock, Perléon
K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Apr 2025
TEMP MASTER, PMMA-based dental resin
K243951 · Taiwan Dental Materials Co., Ltd. · Feb 2025