Cleared Traditional

K931808 - DUCERAGOLD, DUCERATIN

K931808 is an FDA 510(k) clearance for DUCERAGOLD, manufactured by Degussa AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K931808

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.

ELL Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K931808.
MATCHMAKER/PROPAQUE PORCELAIN
K960770 · Davis Schottlander & Davis, Ltd. · Nov 1996
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