ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A


Device Classification Name

material, tooth shade, resin

510(k) Number K112044
Device Name ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
Applicant
ANAXDENT GMBH
14500 fim 470
tarpley, 
TX 
78883

Applicant Contact john balistreri
Correspondent
ANAXDENT GMBH
14500 fim 470
tarpley, 
TX 
78883

Correspodent Contact john balistreri
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 07/18/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No