Denjoy Dental Co Ltd · 89-08 · CHINA
For Denjoy Dental 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 DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT | DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT; product code is 76 E - - BZ Activator, Ultraviolet, For Polymerization | 80 K - - YT Light, Examination, Medical, Battery Powered; date published is 11/21/2016; address is Bldg A4 F 4 , NO. 229 Guyuan Road , Changsha, Hunan CHINA, verified against its source on 2026-09-30.
- Firm
- Denjoy Dental 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 A4 F 4 , NO. 229 Guyuan Road , Changsha, Hunan CHINA verified
- Date published
- 11/21/2016 verified
- Product code
- 76 E - - BZ Activator, Ultraviolet, For Polymerization | 80 K - - YT Light, Examination, Medical, Battery Powered each item verified
- Product
- DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT | DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT each item verified
- FDA notes
- Class II device without a valid 510K | Class II device without a valid 510K each item verified
What the source says
Denjoy Dental Co Ltd Date Published : 11/21/2016 Bldg A4 F 4 , NO. 229 Guyuan Road , Changsha, Hunan 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 - - BZ Activator, Ultraviolet, For Polymerization Date Published: 11/21/2016 Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT Notes: Class II device without a valid 510K 80 K - - YT Light, Examination, Medical, Battery Powered Date Published: 11/21/2016 Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT Notes: Class II device without a valid 510K
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html