Shanghai Smedent Medical Instrument Co., Ltd. · 89-08 · CHINA
For Shanghai Smedent Medical Instrument Co., Ltd., import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- 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
— 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.
Product code, Product and FDA notes
76 E - - LC Scaler, Ultrasonic Date Published: 08/10/2011 Desc: Ultrasonic Scaler (B5 Model) Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html