DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER

Device Classification Name

scaler, ultrasonic

510(k) Number K033044
Device Name DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
Applicant
AMERICAN GREEN DENT. MFG, INC.
3432 e. 14th street
los angeles, 
CA 
90023

Applicant Contact andrew rowe
Correspondent
AMERICAN GREEN DENT. MFG, INC.
3432 e. 14th street
los angeles, 
CA 
90023

Correspodent Contact andrew rowe
Regulation Number 872.4850
Classification Product Code
ELC  
Date Received 09/29/2003
Decision Date 12/21/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No