Cleared Traditional

PERIOGARD(R) PERIOPEN (K901955) - FDA 510(k) Clearance

Class I Dental device.

K901955 · Colgate-Palmolive Co. · Dental device
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Apr 1991
Decision
349d
Days
Class 1
Risk

K901955 is an FDA 510(k) clearance for the PERIOGARD(R) PERIOPEN. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Colgate-Palmolive Co. (Piscataway, US). The FDA issued a Cleared decision on April 15, 1991 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Colgate-Palmolive Co. devices

Submission Details

510(k) Number K901955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date April 15, 1991
Days to Decision 349 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 127d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.