Cleared Traditional

K132937 - HARVEST DENTAL POLYMER BLOCKS (ZCAD

K132937 is an FDA 510(k) clearance for HARVEST DENTAL POLYMER BLOCKS (ZCAD, 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 245-day FDA review.

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

FDA 510(k) Submission Details - K132937

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.

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 113
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K132937.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
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STRUCTUR 3
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TEMPFLEX
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