Cleared Traditional

K023232 - SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (FDA 510(k) Clearance)

K023232 · Smartpractice · Dental device

Dec 2002

Decision

75d

Days

Class 1

Risk

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

Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on December 11, 2002, 75 days after receiving the submission on September 27, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6510.

Submission Details

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