Cleared Traditional

K813328 - MYERSON/KENSON GP POLYMER

K813328 is an FDA 510(k) clearance for MYERSON/KENSON GP POLYMER, manufactured by Howmedica Corp.. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K813328 · Howmedica Corp. · Dental device
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Feb 1982
Decision
92d
Days
Class 2
Risk

K813328 is an FDA 510(k) clearance for the MYERSON/KENSON GP POLYMER. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K813328

510(k) Number K813328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date February 24, 1982
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 44
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K813328.
CBM, CORE BUILD-UP MATERIAL
K823732 · Scientific Pharmaceuticals, Inc. · Dec 1982
COMMAND BONDING RESIN/GLAZE/OPAQUER
K822869 · Sybron Corp. · Oct 1982
CONCLUDE COMPOSITE LUTING CEMENT
K822714 · 3M Company · Sep 1982
SCI-PHARM PAINT-ON RESTORATIVE
K791067 · Scientific Pharmaceuticals, Inc. · Aug 1979
ANTERIOR/POSTERIOR RESTORATIVE, BOND
K791078 · Scientific Pharmaceuticals, Inc. · Aug 1979
COLORANT
K790438 · Vivadent (Usa), Inc. · Apr 1979