Cleared Traditional

K932792 - PULPDENT MALEIC ACID ETCHANTS

K932792 is the FDA 510(k) clearance for PULPDENT MALEIC ACID ETCHANTS by Pulpdent Corp.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K932792 · Pulpdent Corp. · Dental device
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Sep 1993
Decision
92d
Days
Class 2
Risk

K932792 is an FDA 510(k) clearance for the PULPDENT MALEIC ACID ETCHANTS. 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 9, 1993 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 872.3690 - 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 K932792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date September 09, 1993
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 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 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932792.
AMELOGEN RESTORATIVE MATERIALS
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ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE
K931867 · Ultradent Products, Inc. · Sep 1993
VLC DR MATERIAL
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BISCO D/C CORE COMPOSITE
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VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993