Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K062281 |
Device Name |
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 |
Applicant |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Applicant Contact |
ERIN L MCVEY |
Correspondent |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Correspondent Contact |
ERIN L MCVEY |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 08/07/2006 |
Decision Date | 09/05/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|