TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16


Device Classification Name

implant, endosseous, root-form

510(k) Number K072589
Device Name TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
Applicant
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad, 
CA 
92008 -7308

Applicant Contact william fisher
Correspondent
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad, 
CA 
92008 -7308

Correspodent Contact william fisher
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/14/2007
Decision Date 10/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls