Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K200827 |
Device Name |
LOCATOR R-Tx |
Applicant |
Ivory Super Holdco, Incp. |
2875 Locker Ave East |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Marysa Loustalot |
Correspondent |
Ivory Super Holdco, Incp. |
2875 Locker Ave East |
Carlsbad,
CA
92010
|
|
Correspondent Contact |
Marysa Loustalot |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/30/2020 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|