SAESHIN PRECISION CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- 52 Secheonro1-Gil , Dasa-Eup , Dalseong, Daegu KOREA (THE REPUBLIC OF) verified
- Date published
- 07/03/2025 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Class II | Class II | Class II | Class II | Class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html