Denjoy Dental Co Ltd · 89-08 · CHINA
For Denjoy Dental 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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