Cleared Traditional

K992727 - THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM

K992727 is an FDA 510(k) clearance for THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT ..., manufactured by Mds. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K992727 · Mds · Dental device
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Jan 2000
Decision
158d
Days
Class 2
Risk

K992727 is an FDA 510(k) clearance for the THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Mds (Great Neck, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 158 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K992727

510(k) Number K992727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1999
Decision Date January 18, 2000
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 K992727.
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001
WHITE MTA MATERIAL
K011009 · Dentsply International · May 2001
ENDOREZ
K992097 · Ultradent Products, Inc. · Oct 1999
ROEKO SEAL
K983037 · Roeko Ulm, Roescheisen GmbH & Co. · Oct 1998
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998