Cleared Traditional

OXY-GLIDE ROOT CANAL CLEANSER & LUB. (K992919) - FDA 510(k) Clearance

K992919 · Super Glide, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
81d
Days
-
Risk

K992919 is an FDA 510(k) clearance for the OXY-GLIDE ROOT CANAL CLEANSER & LUB.. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Super Glide, Inc. (Burlington, US). The FDA issued a Cleared decision on November 19, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Super Glide, Inc. devices

Submission Details

510(k) Number K992919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date November 19, 1999
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -