Cleared Traditional

DEN-MAT LAMI-QUICK (K895269) - FDA 510(k) Clearance

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

K895269 · Den-Mat Corp. · Dental device
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Feb 1990
Decision
183d
Days
Class 2
Risk

K895269 is an FDA 510(k) clearance for the DEN-MAT LAMI-QUICK. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 183 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Den-Mat Corp. devices

Submission Details

510(k) Number K895269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date February 22, 1990
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 127d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 8
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K895269.
Additive Manufacturing Zirconia Customized Restoration
K240586 · Hangzhou Thales Medtech Co., Ltd. · Oct 2024
Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
SPECTRUM
K880774 · Dentsply Intl. · May 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986