Cleared Traditional

K902972 - FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)

K902972 is the FDA 510(k) clearance for FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) by Cmp Industries, LLC. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902972 · Cmp Industries, LLC · Dental device
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Oct 1990
Decision
90d
Days
Class 2
Risk

K902972 is an FDA 510(k) clearance for the FLEXOR (DENTURE ACRYLIC RELINE MATERIAL). 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 October 4, 1990 after a review of 90 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.

View all Cmp Industries, LLC devices

Submission Details

510(k) Number K902972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1990
Decision Date October 04, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K902972.
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · Heraeus Kulzer, Inc. · Oct 1991
MELIODENT, DENTURE RESIN
K910465 · Heraeus Kulzer, Inc. · Jun 1991
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
SR-IVOCAP
K896130 · Ivoclar North America, Inc. · Apr 1990
SR-IVOSEAL
K896139 · Ivoclar North America, Inc. · Apr 1990
LITELINE VLC SOFT RELINE
K895742 · Dentsply Intl. · Dec 1989