Cleared Traditional

K972234 - RCT GEL ROOT CANAL THERAPY GEL (FDA 510(k) Clearance)

Class I Dental device.

K972234 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
14d
Days
Class 1
Risk

K972234 is an FDA 510(k) clearance for the RCT GEL ROOT CANAL THERAPY GEL. Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 30, 1997 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K972234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date June 30, 1997
Days to Decision 14 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
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIC Syringe, Periodontic, Endodontic, Irrigating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.