Cleared Traditional

K072851 - POLYSTAR 79 DENTURE BASE RESIN

K072851 is an FDA 510(k) clearance for POLYSTAR 79 DENTURE BASE RESIN, manufactured by Cmp Industries, LLC. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K072851 · Cmp Industries, LLC · Dental device
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Feb 2008
Decision
139d
Days
Class 2
Risk

K072851 is an FDA 510(k) clearance for the POLYSTAR 79 DENTURE BASE RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Cmp Industries, LLC (Albany, US). The FDA issued a Cleared decision on February 20, 2008 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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.

FDA 510(k) Submission Details - K072851

510(k) Number K072851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2007
Decision Date February 20, 2008
Days to Decision 139 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 128d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 311
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K072851.
LANG DENTAL ACRYLIC PRIMER
K081981 · Lang Dental Mfg. Co., Inc. · Nov 2008
MAJOR.BASE 20
K081884 · Major Prodotti Dentari S.P.A. · Oct 2008
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
K081514 · Lang Dental Mfg. Co., Inc. · Sep 2008
SMH FLEX S
K073040 · Smh Biomaterial AG · Dec 2007
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
K072479 · Rapid Injection Systems Corp. · Nov 2007
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23
K072580 · Lang Dental Mfg. Co., Inc. · Nov 2007
K072851 · POLYSTAR 79 DENTURE BASE RESIN
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