Cleared Traditional

K932791 - PULPDENT EDTA PREPARATIONS

K932791 is an FDA 510(k) clearance for PULPDENT EDTA PREPARATIONS, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K932791

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.

KIF Device Classification - Class 2, Special Controls

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 127
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