TENDER ORTHO BOND-ENA BOND-ENA ETCH


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K072978
Device Name TENDER ORTHO BOND-ENA BOND-ENA ETCH
Applicant
MICERIUM S.P.A.
via marconi 83
avegno, genoa, 

IT

16030

Applicant Contact eugenio miceli
Correspondent
MICERIUM S.P.A.
via marconi 83
avegno, genoa, 

IT

16030

Correspodent Contact eugenio miceli
Regulation Number 872.3750
Classification Product Code
DYH  
Date Received 10/22/2007
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No