SPI ONETIME DENTAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K022038
Device Name SPI ONETIME DENTAL IMPLANT
Original Applicant
PAXMED INTERNATIONAL
4329 graydon rd.
san diego, 
CA 
92130

Original Contact floyd g larson
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 06/24/2002
Decision Date 07/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No