# SAESHIN PRECISION CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For SAESHIN PRECISION CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; 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)"; country is KOREA (THE REPUBLIC OF); 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 2026-09-16.

- **Firm:** SAESHIN PRECISION CO., LTD. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 52 Secheonro1-Gil , Dasa-Eup , Dalseong, Daegu KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 07/03/2025 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> SAESHIN PRECISION CO., LTD. Date Published : 07/03/2025 52 Secheonro1-Gil , Dasa-Eup , Dalseong, Daegu KOREA (THE REPUBLIC OF) 76 D - - ZA Drill, Dental, Intraoral Date Published: 07/03/2025 Desc: Maxima XL2 Brushless Micromotor System Notes: Class II 76 E - - BW Controller, Foot, Handpiece And Cord Date Published: 07/03/2025 Desc: Maxima XL2 Brushless Micromotor System Notes: Class II 76 E - - GS Handpiece, Contra- And Right-Angle Attachment, Dental Date Published: 07/03/2025 Desc: Maxima XL2 Brushless Micromotor System Notes: Class II 76 E - - KY Handpiece, Water-Powered Date Published: 07/03/2025 Desc: Maxima XL2 Brushless Micromotor System Notes: Class II 76 E - - LC Scaler, Ultrasonic Date Published: 07/03/2025 Desc: Maxima XL2 Brushless Micromotor System Notes: Class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).