RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS


Device Classification Name

implant, endosseous, root-form

510(k) Number K072768
Device Name RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
Applicant
LIFECORE BIOMEDICAL, INC.
3515 lyman blvd.
chaska, 
MN 
55318

Applicant Contact karen clement
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 lyman blvd.
chaska, 
MN 
55318

Correspodent Contact karen clement
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/28/2007
Decision Date 10/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No