JUELL HARD CURE


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K111177
Device Name JUELL HARD CURE
Applicant
JUELL DENTAL
2401 n commerce
ardmore, 
OK 
73401

Applicant Contact angela blackwell
Correspondent
JUELL DENTAL
2401 n commerce
ardmore, 
OK 
73401

Correspodent Contact angela blackwell
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 04/27/2011
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