Cleared Traditional

K962885 - SEALEX EXTRA ROOT CANAL SEALER

K962885 is an FDA 510(k) clearance for SEALEX EXTRA ROOT CANAL SEALER, manufactured by Baladent. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K962885 · Baladent · Dental device
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Aug 1996
Decision
37d
Days
Class 2
Risk

K962885 is an FDA 510(k) clearance for the SEALEX EXTRA ROOT CANAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Baladent (Chicago, US). The FDA issued a Cleared decision on August 30, 1996 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baladent devices

FDA 510(k) Submission Details - K962885

510(k) Number K962885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1996
Decision Date August 30, 1996
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 124
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K962885.
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K971622 · Mpl Technologies, Inc. · Jun 1997
MINERAL TRIOXIDE AGGREGATE (MTA)
K964174 · Tulsa Dental Products, Ltd. · Feb 1997
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922 · Wallace A. Erickson & Co. · Dec 1996
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K955703 · Neodental Chemical Products Co., Ltd. · May 1996
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995