Cleared Traditional

K972369 - SEALAPEX

K972369 is an FDA 510(k) clearance for SEALAPEX, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K972369

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.

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 117
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K972369.
ENDOSOLV E
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ENDO-SEAL
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K971622 · Mpl Technologies, Inc. · Jun 1997
MINERAL TRIOXIDE AGGREGATE (MTA)
K964174 · Tulsa Dental Products, Ltd. · Feb 1997