Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K190192 |
Device Name |
K3Pro Konus New Abutments and Implants |
Applicant |
Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg |
Franz-Kirsten-Str. 1 |
Bingen Am Rhein,
DE
55411
|
|
Applicant Contact |
Richard Donaca |
Correspondent |
Argon Dental USA, LLC |
1000 Corporate Drive |
Marshfield,
WI
54449
|
|
Correspondent Contact |
Celline Lakus |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/04/2019 |
Decision Date | 02/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|