Cleared Traditional

K901955 - PERIOGARD(R) PERIOPEN

K901955 is an FDA 510(k) clearance for PERIOGARD PERIOPEN, manufactured by Colgate-Palmolive Co.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 349-day FDA review.

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.

FDA 510(k) Submission Details - K901955

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 128d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFS Unit, Oral Irrigation

All 44
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K901955.
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K921999 · Bausch & Lomb, Inc. · Jun 1992
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · Smith & Nephew, Inc. · Sep 1991
OXYFRESH OXYCARE 3000
K910832 · Oxyfresh · Apr 1991
PERIO PIK
K905188 · Teledyne Water Pik · Feb 1991
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
K904850 · Micro Motors, Inc. · Jan 1991
L'LL SQUIRT GUM ORAL RINSE DEVICE
K897053 · James R. Powell · Aug 1990
K901955 · PERIOGARD(R) PERIOPEN
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