Cleared Traditional

K093208 - SIMPLISEAL

K093208 is an FDA 510(k) clearance for SIMPLISEAL, manufactured by Discus Dental, LLC. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K093208 · Discus Dental, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
122d
Days
Class 2
Risk

K093208 is an FDA 510(k) clearance for the SIMPLISEAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Discus Dental, LLC (Culver City, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 122 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.

FDA 510(k) Submission Details - K093208

510(k) Number K093208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date February 12, 2010
Days to Decision 122 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 128d · This submission: 122d
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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K093208.
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
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BIODENTINE
K092251 · Septodont · Oct 2009
IROOT BP PLUS
K092715 · Innovative Bioceramix, Inc. · Sep 2009
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009
K093208 · SIMPLISEAL
Download PDF FDA Summary Discus Dental, LLC