Cleared Traditional

K981647 - 3M DENT II SYSTEM

K981647 is an FDA 510(k) clearance for 3M DENT II SYSTEM, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981647 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
90d
Days
Class 2
Risk

K981647 is an FDA 510(k) clearance for the 3M DENT II SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on August 9, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K981647

510(k) Number K981647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date August 09, 1998
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K981647.
DYTRACT FLOW RESTORATIVE
K982395 · Dentsply Intl. · Aug 1998
ESTENIA
K982164 · Kuraray America, Inc. · Aug 1998
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
K982201 · Foremost Dental Mfg., Inc. · Aug 1998
PRODIGY 2
K982148 · Sybron Dental Specialties, Inc. · Jul 1998
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
K981562 · Sulzer Calcitek, Inc. · Jul 1998
PERMACEM AUTOMIX LUTING CEMENT SYSTEM
K981813 · Foremost Dental Mfg., Inc. · Jul 1998