SMH FLEX S


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K073040
Device Name SMH FLEX S
Applicant
SMH BIOMATERIAL AG
3537 teasley lane
denton, 
TX 
76210

Applicant Contact ashley truitt
Correspondent
SMH BIOMATERIAL AG
3537 teasley lane
denton, 
TX 
76210

Correspodent Contact ashley truitt
Regulation Number 872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received 10/29/2007
Decision Date 12/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No