Cleared Traditional

K972369 - SEALAPEX

K972369 is the FDA 510(k) clearance for SEALAPEX by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K972369 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
51d
Days
Class 2
Risk

K972369 is an FDA 510(k) clearance for the SEALAPEX. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 51 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K972369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date August 15, 1997
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
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 73
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K972369.
ENDOREZ
K992097 · Ultradent Products, Inc. · Oct 1999
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998
ENDO-SEAL
K971899 · Ultradent Products, Inc. · Jun 1997
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995