Cleared Traditional

K931808 - DUCERAGOLD

K931808 is the FDA 510(k) clearance for DUCERAGOLD by Degussa AG. It is a Class 2 Dental device (product code ELL) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K931808 · Degussa AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
205d
Days
Class 2
Risk

K931808 is an FDA 510(k) clearance for the DUCERAGOLD, DUCERATIN. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 205 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 Degussa AG devices

Submission Details

510(k) Number K931808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1993
Decision Date November 03, 1993
Days to Decision 205 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 127d · This submission: 205d
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 24
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K931808.
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
K960480 · Vident · Mar 1996
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
K930835 · Ivoclar North America, Inc. · Jul 1994
IPS CERAMIC ETCHING GEL
K923926 · Ivoclar North America, Inc. · Oct 1992
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460 · Pulpdent Corp. · Apr 1992
TYCERAMIC
K910569 · Jeneric/Pentron, Inc. · Apr 1991