Cleared Traditional

DUCERATIN/DUCERAM LFC DENTAL PORCELAIN (K921479) - FDA 510(k) Clearance

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

K921479 · Degussa AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
84d
Days
Class 2
Risk

K921479 is an FDA 510(k) clearance for the DUCERATIN/DUCERAM LFC DENTAL PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Degussa AG devices

Submission Details

510(k) Number K921479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date June 22, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K921479.
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
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