Cleared Traditional

K940368 - CANAL KING (THIN) CANAL KING (THICK)

K940368 is an FDA 510(k) clearance for CANAL KING (THIN) CANAL KING (THICK), 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 359-day FDA review.

K940368 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
359d
Days
Class 2
Risk

K940368 is an FDA 510(k) clearance for the CANAL KING (THIN) CANAL KING (THICK). 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 January 20, 1995 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K940368

510(k) Number K940368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date January 20, 1995
Days to Decision 359 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 127d · This submission: 359d
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 K940368.
SEALEX EXTRA ROOT CANAL SEALER
K962885 · Baladent · Aug 1996
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K955703 · Neodental Chemical Products Co., Ltd. · May 1996
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
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