Cleared Traditional

K023232 - SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

K023232 is an FDA 510(k) clearance for SPLATRFREE SWANGLE 360 DISPOSABLE PROPH..., manufactured by Smartpractice. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K023232 · Smartpractice · Dental device
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Dec 2002
Decision
75d
Days
Class 1
Risk

K023232 is an FDA 510(k) clearance for the SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on December 11, 2002 after a review of 75 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 - K023232

510(k) Number K023232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date December 11, 2002
Days to Decision 75 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
53d faster than avg
Panel avg: 128d · This submission: 75d
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 41
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K023232.
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · Air Force, Inc. · Oct 2000
AGATHA-A-H2010
K983374 · Midian Intl. · Dec 1998
DERMADAM
K964810 · Ultradent Products, Inc. · Feb 1997
BARRIER ALL FILM
K952234 · Cottrell, Ltd. · Jul 1995
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K943182 · Oral-B Laboratories · Sep 1994
PERIOFLEX TIP
K923711 · Novadent, Ltd. · May 1994
K023232 · SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
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