Cleared Traditional

RANIR HI-TECHNOLOGY DENTAL FLOSS (K955530) - FDA 510(k) Clearance

Class I Dental device.

K955530 · Ranir/Dcp Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
24d
Days
Class 1
Risk

K955530 is an FDA 510(k) clearance for the RANIR HI-TECHNOLOGY DENTAL FLOSS. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Ranir/Dcp Corp. devices

Submission Details

510(k) Number K955530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date December 28, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.