Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K161598 |
Device Name |
NobelZygoma 0° |
Applicant |
Nobel Biocare AB |
Box 5190, SE-402 26, Vastra Hamngatan I |
Goteborg,
SE
SE-411 17
|
|
Applicant Contact |
Charlemagne Chua |
Correspondent |
Nobel Biocare USA LLC |
22715 Savi Ranch Parkway |
Yorba Linda,
CA
92887
|
|
Correspondent Contact |
Charlemagne Chua |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2016 |
Decision Date | 03/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|