Cleared Traditional

DEN-MAT CERINATE PORCELAIN (K895731) - FDA 510(k) Clearance

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

K895731 · Den-Mat Corp. · Dental device
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Aug 1990
Decision
311d
Days
Class 2
Risk

K895731 is an FDA 510(k) clearance for the DEN-MAT CERINATE PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on August 3, 1990 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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. Elevated predicate reliance profile. 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 K895731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date August 03, 1990
Days to Decision 311 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 127d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K895731.
FINESSE PORCELAIN SYSTEM
K940252 · Dentsply Intl. · Mar 1994
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · Dentsply Intl. · Nov 1985
SCOTCHPRIME CERAMIC PRIMER
K853698 · 3M Company · Nov 1985