Cleared Traditional

RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690) - FDA 510(k) Clearance

Class I Dental device.

K942690 · Ranir/Dcp Corp. · Dental device
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Apr 1995
Decision
324d
Days
Class 1
Risk

K942690 is an FDA 510(k) clearance for the RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6390 - 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. Elevated predicate reliance profile. 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 Ranir/Dcp Corp. devices

Submission Details

510(k) Number K942690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date April 27, 1995
Days to Decision 324 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
197d slower than avg
Panel avg: 127d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JES Floss, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.