Shanghai Smedent Medical Instrument Co., Ltd. · 89-08 · CHINA
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
- 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
- Address
- Bldg. 10 Th Suite 310 , 3599 Qixin Rd , Shanghai, Shanghai CHINA verified
- Date published
- 08/10/2011 verified
- Product code
- 76 E - - LC Scaler, Ultrasonic verified
- Product
- Ultrasonic Scaler (B5 Model) verified
- FDA notes
- Class II verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.