Cleared Traditional

K905188 - PERIO PIK

K905188 is an FDA 510(k) clearance for PERIO PIK, manufactured by Teledyne Water Pik. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K905188 · Teledyne Water Pik · Dental device
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Feb 1991
Decision
88d
Days
Class 1
Risk

K905188 is an FDA 510(k) clearance for the PERIO PIK. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Teledyne Water Pik (Fort Collins, US). The FDA issued a Cleared decision on February 15, 1991 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K905188

510(k) Number K905188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date February 15, 1991
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
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 26
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K905188.
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · Smith & Nephew, Inc. · Sep 1991
OXYFRESH OXYCARE 3000
K910832 · Oxyfresh · Apr 1991
PERIOGARD(R) PERIOPEN
K901955 · Colgate-Palmolive Co. · Apr 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
OSSEOTITE IRRIGATION UNIT
K901600 · Collagen Corp. · Jun 1990
K905188 · PERIO PIK
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