The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Strong Dental Handpieces.
| Device ID | K181129 |
| 510k Number | K181129 |
| Device Name: | STRONG Dental Handpieces |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 42921 |
| Contact | Choi Jong Woo |
| Correspondent | Choi Jong Woo Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, KR 42921 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2019-01-31 |