MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK


Device Classification Name

implant, endosseous, root-form

510(k) Number K033630
Device Name MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
Applicant
RHEIN 83 SRL
132 monroe st.
hoboken, 
NJ 
07030

Applicant Contact joseph e grasso
Correspondent
RHEIN 83 SRL
132 monroe st.
hoboken, 
NJ 
07030

Correspodent Contact joseph e grasso
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 11/17/2003
Decision Date 04/21/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No