Cleared Traditional

FLUOCAL GEL ORANGE (K760799) - FDA 510(k) Clearance

K760799 · Septodont, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
47d
Days
-
Risk

K760799 is an FDA 510(k) clearance for the FLUOCAL GEL ORANGE.

Submitted by Septodont, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1976 after a review of 47 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 Septodont, Inc. devices

Submission Details

510(k) Number K760799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1976
Decision Date November 24, 1976
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -