APROXI 1100 AND 4000 SERIES DENTAL INLAYS


Device Classification Name

material, tooth shade, resin

510(k) Number K073047
Device Name APROXI 1100 AND 4000 SERIES DENTAL INLAYS
Applicant
APROXI APS
hojeloft vaenge 206
vaerlose, 

DK

Applicant Contact kirsten rono
Correspondent
APROXI APS
hojeloft vaenge 206
vaerlose, 

DK

Correspodent Contact kirsten rono
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 10/29/2007
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No