Cleared Traditional

HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (K132937) - FDA 510(k) Clearance

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

K132937 · Harvest Dental Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
245d
Days
Class 2
Risk

K132937 is an FDA 510(k) clearance for the HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA). Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Harvest Dental Products, LLC (Sarasota, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 245 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 K132937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date May 21, 2014
Days to Decision 245 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
118d slower than avg
Panel avg: 127d · This submission: 245d
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 63
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K132937.
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
MSN-006
K141562 · GC America, Inc. · Sep 2014
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
UNIFAST III
K073106 · GC America, Inc. · Apr 2008