SAESHIN PRECISION CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)

For SAESHIN PRECISION CO., LTD., import alert is 89-08; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Maxima XL2 Brushless Micromotor System | Maxima XL2 Brushless Micromotor System | Maxima XL2 Brushless Micromotor System | Maxima XL2 Brushless Micromotor System | Maxima XL2 Brushless Micromotor System; product code is 76 D - - ZA Drill, Dental, Intraoral | 76 E - - BW Controller, Foot, Handpiece And Cord | 76 E - - GS Handpiece, Contra- And Right-Angle Attachment, Dental | 76 E - - KY Handpiece, Water-Powered | 76 E - - LC Scaler, Ultrasonic; date published is 07/03/2025; address is 52 Secheonro1-Gil , Dasa-Eup , Dalseong, Daegu KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

SAESHIN PRECISION CO., LTD. Date Published : 07/03/2025 52 Secheonro1-Gil , Dasa-Eup , Dalseong, Daegu KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.