Cleared Traditional

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL (K920460) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 8
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K920460.
Additive Manufacturing Zirconia Customized Restoration
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Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
SPECTRUM
K880774 · Dentsply Intl. · May 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986