Cleared Traditional

PULPDENT 2.5% NITRIC ACID ETCHANT (K932793) - FDA 510(k) Clearance

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

K932793 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
96d
Days
Class 2
Risk

K932793 is an FDA 510(k) clearance for the PULPDENT 2.5% NITRIC ACID ETCHANT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 13, 1993 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K932793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date September 13, 1993
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932793.
DYRACT II RESTORATIVE
K950991 · Dentsply Intl. · Mar 1995
TOTAL ETCH GEL
K945769 · Dentsply Intl. · Dec 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994
VLC DR MATERIAL
K932395 · Dentsply Intl. · Aug 1993
TRIAD INLAY COMPOSITE
K923236 · Dentsply Intl. · Sep 1992
3M BRAND RESTORATIVE Z100
K920425 · 3M Company · Mar 1992