STRAUMANN TIBRUSH


Device Classification Name

scaler, rotary

510(k) Number K111724
Device Name STRAUMANN TIBRUSH
Applicant
STRAUMANN USA
60 minuteman road
andover, 
MA 
01810

Applicant Contact elaine alan
Correspondent
STRAUMANN USA
60 minuteman road
andover, 
MA 
01810

Correspodent Contact elaine alan
Regulation Number 872.4840
Classification Product Code
ELB  
Date Received 06/20/2011
Decision Date 09/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No