ACCELEDENT


Device Classification Name

orthodontic vibratory accessory

510(k) Number K110661
Device Name ACCELEDENT
Applicant
ORTHOACCEL TECHNOLOGIES, INC
8275 el rio,
suite 100
houston, 
TX 
77054

Applicant Contact michael e kaufman
Correspondent
ORTHOACCEL TECHNOLOGIES, INC
8275 el rio,
suite 100
houston, 
TX 
77054

Correspodent Contact michael e kaufman
Regulation Number 872.5470
Classification Product Code
OYH  
Date Received 03/08/2011
Decision Date 11/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No