Cleared Traditional

K920460 - 4% ACIDULATED PHOSPHATE FLUORIDE ETCHIN...

K920460 is the FDA 510(k) clearance for 4% ACIDULATED PHOSPHATE FLUORIDE ETCHIN... by Pulpdent Corp.. It is a Class 2 Dental device (product code ELL) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K920460 · Pulpdent Corp. · Dental device
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Apr 1992
Decision
92d
Days
Class 2
Risk

K920460 is an FDA 510(k) clearance for the 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 92 days - within the typical 510(k) review window.

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 Pulpdent Corp. devices

Submission Details

510(k) Number K920460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date April 28, 1992
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 K920460.
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
K930835 · Ivoclar North America, Inc. · Jul 1994
DUCERAGOLD, DUCERATIN
K931808 · Degussa AG · Nov 1993
IPS CERAMIC ETCHING GEL
K923926 · Ivoclar North America, Inc. · Oct 1992
TYCERAMIC
K910569 · Jeneric/Pentron, Inc. · Apr 1991
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991
PROCERAM PORCELAIN
K903907 · Nobelpharma USA, Inc. · Nov 1990