Cleared Traditional

K931380 - WATER PIK PLUS PLAQUE CONTROL SYSTEM

K931380 is an FDA 510(k) clearance for WATER PIK PLUS PLAQUE CONTROL SYSTEM, 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 186-day FDA review.

K931380 · Teledyne Water Pik · Dental device
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Sep 1993
Decision
186d
Days
Class 1
Risk

K931380 is an FDA 510(k) clearance for the WATER PIK PLUS PLAQUE CONTROL SYSTEM. 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 September 20, 1993 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K931380

510(k) Number K931380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1993
Decision Date September 20, 1993
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 128d · This submission: 186d
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 K931380.
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K943182 · Oral-B Laboratories · Sep 1994
PERIOFLEX TIP
K923711 · Novadent, Ltd. · May 1994
HYDRO FLOSS
K923937 · Hydro Floss, Inc. · Feb 1994
SHOWERFLOSS
K923457 · Summit Marketing Group, Inc. · Sep 1992
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K921999 · Bausch & Lomb, Inc. · Jun 1992
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · Smith & Nephew, Inc. · Sep 1991
K931380 · WATER PIK PLUS PLAQUE CONTROL SYSTEM
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