Cleared Traditional

K932793 - PULPDENT 2.5% NITRIC ACID ETCHANT

K932793 is an FDA 510(k) clearance for PULPDENT 2.5% NITRIC ACID ETCHANT, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K932793 · Pulpdent Corp. · Dental device
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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

FDA 510(k) Submission Details - K932793

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 797
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932793.
ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE
K932886 · Wallace A. Erickson & Co. · Sep 1993
CONQUEST CRYSTAL
K932154 · Jeneric/Pentron, Inc. · Sep 1993
AMELOGEN RESTORATIVE MATERIALS
K932227 · Ultradent Products, Inc. · Sep 1993
ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE
K931867 · Ultradent Products, Inc. · Sep 1993
PULPDENT MALEIC ACID ETCHANTS
K932792 · Pulpdent Corp. · Sep 1993
VLC DR MATERIAL
K932395 · Dentsply Intl. · Aug 1993