# Shanghai Smedent Medical Instrument Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shanghai Smedent Medical Instrument Co., Ltd. · 89-08 · CHINA, 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 CHINA; product is Ultrasonic Scaler (B5 Model); product code is 76 E - - LC Scaler, Ultrasonic; date published is 08/10/2011; address is Bldg. 10 Th Suite 310 , 3599 Qixin Rd , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

- **Firm:** Shanghai Smedent Medical Instrument 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:** CHINA _(verified: appears in the quote below)_
- **Address:** Bldg. 10 Th Suite 310 , 3599 Qixin Rd , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 08/10/2011 _(verified: appears in the quote below)_
- **Product code:** 76 E - - LC Scaler, Ultrasonic _(verified: appears in the quote below)_
- **Product:** Ultrasonic Scaler (B5 Model) _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Shanghai Smedent Medical Instrument Co., Ltd. Date Published : 08/10/2011 Bldg. 10 Th Suite 310 , 3599 Qixin Rd , Shanghai, Shanghai CHINA 76 E - - LC Scaler, Ultrasonic Date Published: 08/10/2011 Desc: Ultrasonic Scaler (B5 Model) 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/).