Cleared Traditional

K040343 - TEMP F

K040343 is an FDA 510(k) clearance for TEMP F, manufactured by Novocol, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K040343 · Novocol, Inc. · Dental device
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Aug 2004
Decision
173d
Days
Class 2
Risk

K040343 is an FDA 510(k) clearance for the TEMP F. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Novocol, Inc. (Louisville, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 173 days - an extended review 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: 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.

View all Novocol, Inc. devices

FDA 510(k) Submission Details - K040343

510(k) Number K040343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2004
Decision Date August 03, 2004
Days to Decision 173 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
46d slower than avg
Panel avg: 127d · This submission: 173d
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 353
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K040343.
IONOFIL PLUS AC
K042669 · Voco GmbH · Oct 2004
DYRACT CEM PLUS CEMENT
K041272 · Dentsply Intl. · Oct 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · Premier Dental Products Co. · Sep 2004
MAXCEM
K041474 · Sybron Dental Specialties, Inc. · Jul 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004