TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K081514
Device Name TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
Applicant
LANG DENTAL MFG. CO., INC.
175 messner dr.
wheeling, 
IL 
60090 -0969

Applicant Contact chah m shen
Correspondent
LANG DENTAL MFG. CO., INC.
175 messner dr.
wheeling, 
IL 
60090 -0969

Correspodent Contact chah m shen
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 05/30/2008
Decision Date 09/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No