Device Classification Name |
scaler, ultrasonic
|
510(k) Number |
K170104 |
Device Name |
COMPACT S, COMPACT S (LED) |
Applicant |
DMETEC CO., LTD. |
#402-603. Techno-Park, 193, Yakdae-Dong, Wonmi-Ku, Bucheon |
City |
Gyeonggi-do,
KR
|
|
Applicant Contact |
Lee Seung Dae |
Correspondent |
Onbix Corporation |
#821 Samil Plaza, 14, Dogok-ro 1-gil |
Gangnam-gu,
KR
06253
|
|
Correspondent Contact |
Yang Ho Dong |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 01/12/2017 |
Decision Date | 12/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|