Cleared Traditional

K900547 - WATER PIK(R) W/ADD'L CLAIMS

K900547 is an FDA 510(k) clearance for WATER PIK W/ADD'L CLAIMS, 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 130-day FDA review.

K900547 · Teledyne Water Pik · Dental device
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Jun 1990
Decision
130d
Days
Class 1
Risk

K900547 is an FDA 510(k) clearance for the WATER PIK(R) W/ADD'L CLAIMS. 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 June 15, 1990 after a review of 130 days - within the typical 510(k) review window.

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 - K900547

510(k) Number K900547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1990
Decision Date June 15, 1990
Days to Decision 130 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
2d slower than avg
Panel avg: 128d · This submission: 130d
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 K900547.
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
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K900178 · Core-Vent Corp. · May 1990
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K900991 · Tocad America, Inc. · May 1990
DYNASURG DENTAL IRRIGATION SYSTEM
K896890 · Micro Motors, Inc. · Feb 1990
K900547 · WATER PIK(R) W/ADD'L CLAIMS
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