Cleared Traditional

K932791 - PULPDENT EDTA PREPARATIONS

K932791 is the FDA 510(k) clearance for PULPDENT EDTA PREPARATIONS by Pulpdent Corp.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K932791 · Pulpdent Corp. · Dental device
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Sep 1993
Decision
103d
Days
Class 2
Risk

K932791 is an FDA 510(k) clearance for the PULPDENT EDTA PREPARATIONS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 20, 1993 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 K932791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date September 20, 1993
Days to Decision 103 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
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 81
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K932791.
PULPDENT ROOT CANAL SEALER
K946138 · Pulpdent Corp. · Jan 1995
TUBLI-SEAL EWT
K942393 · Sybron Dental Specialties, Inc. · Jun 1994
ALPHA-DENT ROOT CANAL SEALER
K930872 · Wallace A. Erickson & Co. · Feb 1994
ROOT CANAL FILLING CEMENT
K914325 · Confi-Dental Products Co. · Mar 1992
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K896657 · Pulpdent Corp. · Feb 1990