Cleared Traditional

K920460 - 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL

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

K920460 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920460

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.

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 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