Cleared Traditional

K002843 - SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

K002843 is an FDA 510(k) clearance for SULTAN SENSITEMP RESIN TEMPORARY CEMENT, manufactured by Sultan Chemists, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K002843 · Sultan Chemists, Inc. · Dental device
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Nov 2000
Decision
64d
Days
Class 2
Risk

K002843 is an FDA 510(k) clearance for the SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sultan Chemists, Inc. (Kansas City, US). The FDA issued a Cleared decision on November 15, 2000 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Sultan Chemists, Inc. devices

FDA 510(k) Submission Details - K002843

510(k) Number K002843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date November 15, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 394
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K002843.
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
CAVEX TEMPORARY CEMENT
K003791 · Cavex Holland BV · Jan 2001
TEMP-BOND NE 2
K003658 · Sybron Dental Specialties, Inc. · Jan 2001
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · 3M Company · Sep 2000
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · Shofu Dental Corp. · Sep 2000
KETAC CEM U
K002793 · Espe Dental AG · Sep 2000