ORTHO-JET CRYSTAL


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K112397
Device Name ORTHO-JET CRYSTAL
Applicant
LANG DENTAL MFG. CO., INC.
p.o box 969
wheeling, 
IL 
60090 -0969

Applicant Contact david lang
Correspondent
LANG DENTAL MFG. CO., INC.
p.o box 969
wheeling, 
IL 
60090 -0969

Correspodent Contact david lang
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 08/19/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No