Cleared Traditional

K923926 - IPS CERAMIC ETCHING GEL

K923926 is the FDA 510(k) clearance for IPS CERAMIC ETCHING GEL by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code ELL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K923926 · Ivoclar North America, Inc. · Dental device
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Oct 1992
Decision
83d
Days
Class 2
Risk

K923926 is an FDA 510(k) clearance for the IPS CERAMIC ETCHING GEL. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on October 27, 1992 after a review of 83 days - a notably fast clearance 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: 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K923926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date October 27, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 K923926.
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
DUCERAGOLD, DUCERATIN
K931808 · Degussa AG · Nov 1993
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460 · Pulpdent Corp. · Apr 1992
TYCERAMIC
K910569 · Jeneric/Pentron, Inc. · Apr 1991
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991