Cleared Abbreviated

K120283 - DIMER DUAL CURE PERMANENT/TEMPORARY RES...

K120283 is an FDA 510(k) clearance for DIMER DUAL CURE PERMANENT/TEMPORARY RES..., manufactured by Novocol, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Abbreviated 510(k) pathway after a 182-day FDA review.

K120283 · Novocol, Inc. · Dental device
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Jul 2012
Decision
182d
Days
Class 2
Risk

K120283 is an FDA 510(k) clearance for the DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Novocol, Inc. (Louisville, US). The FDA issued a Cleared decision on July 31, 2012 after a review of 182 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novocol, Inc. devices

FDA 510(k) Submission Details - K120283

510(k) Number K120283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date July 31, 2012
Days to Decision 182 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 127d · This submission: 182d
Pathway characteristics
Standards-based clearance path.

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
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