TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE


Device Classification Name

unit, operative dental

510(k) Number K110481
Device Name TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
Applicant
ASI MEDICAL, INC.
14550 e easter ave.
suite 700
centennial, 
CO 
80112

Applicant Contact john mcpeek
Correspondent
ASI MEDICAL, INC.
14550 e easter ave.
suite 700
centennial, 
CO 
80112

Correspodent Contact john mcpeek
Regulation Number 872.6640
Classification Product Code
EIA  
Date Received 02/18/2011
Decision Date 04/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No