SECURE RELINE/PICKUP MATERIAL


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K021586
Device Name SECURE RELINE/PICKUP MATERIAL
Original Applicant
IMTEC CORP.
2401 north commerce
ardmore, 
OK 
73401

Original Contact brad vance
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 05/14/2002
Decision Date 06/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No