| Device Classification Name |
implant, endosseous, root-form
|
|---|
| 510(k) Number |
K182448 |
|---|
| Device Name |
AnyRidge Octa 1 Implant System |
|---|
| Applicant |
| MegaGen Implant Co., Ltd. |
| 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun |
|
Daegu,
KR
|
|
| Applicant Contact |
HyeJin Jung |
| Correspondent |
| LK Consulting Group USA, Inc. |
| 690 Roosevelt |
|
Irvine,
CA
92620
|
|
| Correspondent Contact |
Priscilla Chung |
| Regulation Number | 872.3640
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 09/07/2018 |
|---|
| Decision Date | 10/09/2019 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Dental
|
|---|
| 510k Review Panel |
Dental
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|