Cleared Traditional

K981813 - PERMACEM AUTOMIX LUTING CEMENT SYSTEM

K981813 is an FDA 510(k) clearance for PERMACEM AUTOMIX LUTING CEMENT SYSTEM, manufactured by Foremost Dental Mfg., Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K981813 · Foremost Dental Mfg., Inc. · Dental device
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Jul 1998
Decision
49d
Days
Class 2
Risk

K981813 is an FDA 510(k) clearance for the PERMACEM AUTOMIX LUTING CEMENT SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Chicago, US). The FDA issued a Cleared decision on July 10, 1998 after a review of 49 days - a notably fast clearance cycle.

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: 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 Foremost Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K981813

510(k) Number K981813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 10, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 127d · This submission: 49d
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 799
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K981813.
3M DENT II SYSTEM
K981647 · 3M Company · Aug 1998
PRODIGY 2
K982148 · Sybron Dental Specialties, Inc. · Jul 1998
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
K981562 · Sulzer Calcitek, Inc. · Jul 1998
ARISTON PHC
K981264 · Ivoclar USA, Inc. · Jul 1998
CRISTOBAL
K980018 · Newave Medical, Inc. · May 1998
CU-100A LIGHT CURE UNIT
K980792 · Rolence Enterprise Co. , Ltd. · May 1998