SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE


Device Classification Name

unit, oral irrigation

510(k) Number K023232
Device Name SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
Original Applicant
SMART PRACTICE
3400 east mcdowell rd.
phoenix, 
AZ 
85008

Original Contact kim sullivan
Regulation Number 872.6510
Classification Product Code
EFS  
Date Received 09/27/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No