Cleared Traditional

MATCH MASTER LOW FUSION PORCELAIN (K024252) - FDA 510(k) Clearance

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

K024252 · Davis Schottlander & Davis, Ltd. · Dental device
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Jan 2004
Decision
395d
Days
Class 2
Risk

K024252 is an FDA 510(k) clearance for the MATCH MASTER LOW FUSION PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Davis Schottlander & Davis, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on January 22, 2004 after a review of 395 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 Davis Schottlander & Davis, Ltd. devices

Submission Details

510(k) Number K024252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date January 22, 2004
Days to Decision 395 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 127d · This submission: 395d
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 K024252.
DUCERAM PLUS CERAMIC SYSTEM
K040420 · Dentsply Intl. · Mar 2004
DUCERAGOLD PORCELAINS
K040421 · Dentsply Intl. · Mar 2004
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
3M TR SYSTEM
K992489 · 3M Company · Jan 2000