The following data is part of a premarket notification filed by Dmetec Co., Ltd. with the FDA for Compact S, Compact S (led).
| Device ID | K170104 |
| 510k Number | K170104 |
| Device Name: | COMPACT S, COMPACT S (LED) |
| Classification | Scaler, Ultrasonic |
| Applicant | DMETEC CO., LTD. #402-603. Techno-Park, 193, Yakdae-Dong, Wonmi-Ku, Bucheon City Gyeonggi-do, KR |
| Contact | Lee Seung Dae |
| Correspondent | Yang Ho Dong Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil Gangnam-gu, KR 06253 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2017-12-27 |
| Summary: | summary |