Cleared Traditional

K180578 - Harvest Dental Polymer Blocks

K180578 is an FDA 510(k) clearance for Harvest Dental Polymer Blocks, manufactured by Harvest Dental Products, LLC. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 282-day FDA review.

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

FDA 510(k) Submission Details - K180578

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
Combination Product No
PCCP Authorized No
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.

EBG Device Classification - Class 2, Special Controls

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 112
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K180578.
MD-Temp Plus
K190724 · Meta Biomed Co., Ltd. · Jul 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 2019
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · Blue Dent Dental · Dec 2018
Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016