Device Classification Name |
Crown And Bridge, Temporary, Resin
|
510(k) Number |
K192022 |
Device Name |
DiaTemp Flow |
Applicant |
Diadent Group International |
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu |
Cheongju-si,
KR
28161
|
|
Applicant Contact |
Kab Sun Lee |
Correspondent |
Diadent Group International |
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu |
Cheongju-si,
KR
28161
|
|
Correspondent Contact |
Kab Sun Lee |
Regulation Number | 872.3770
|
Classification Product Code |
|
Date Received | 07/29/2019 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|