TI-MAX X450


Device Classification Name

handpiece, air-powered, dental

510(k) Number K112024
Device Name TI-MAX X450
Applicant
NAKANISHI, INC.
1201 richardson drive
suite 280
richardson, 
TX 
75080

Applicant Contact diane rutherford
Correspondent
NAKANISHI, INC.
1201 richardson drive
suite 280
richardson, 
TX 
75080

Correspodent Contact diane rutherford
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 07/15/2011
Decision Date 06/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No