Cleared Traditional

K790339 - CONCEPT II

K790339 is an FDA 510(k) clearance for CONCEPT II, manufactured by Richardson Merrel, Inc.. The device is a Class 2 Dental device with product code EBE cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K790339 · Richardson Merrel, Inc. · Dental device
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Jul 1979
Decision
146d
Days
Class 2
Risk

K790339 is an FDA 510(k) clearance for the CONCEPT II. Classified as Coating, Denture Hydrophilic, Resin (product code EBE), Class II - Special Controls.

Submitted by Richardson Merrel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1979 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3300 - 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 Richardson Merrel, Inc. devices

FDA 510(k) Submission Details - K790339

510(k) Number K790339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1979
Decision Date July 17, 1979
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBE Device Classification - Class 2, Special Controls

Product Code EBE Coating, Denture Hydrophilic, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3300
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.