Cleared Traditional

SULTAN PERIO-SELECT IRRIGATION SYSTEM (K896826) - FDA 510(k) Clearance

K896826 · Sultan Chemists, Inc. · Dental device
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Mar 1990
Decision
88d
Days
-
Risk

K896826 is an FDA 510(k) clearance for the SULTAN PERIO-SELECT IRRIGATION SYSTEM.

Submitted by Sultan Chemists, Inc. (Westford, US). The FDA issued a Cleared decision on March 2, 1990 after a review of 88 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 Sultan Chemists, Inc. devices

Submission Details

510(k) Number K896826 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 04, 1989
Decision Date March 02, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -