# Denjoy Dental Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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 A4 F 4 , NO. 229 Guyuan Road , Changsha, Hunan CHINA _(verified: appears in the quote below)_
- **Date published:** 11/21/2016 _(verified: appears in the quote below)_
- **Product code:** 76 E - - BZ Activator, Ultraviolet, For Polymerization | 80 K - - YT Light, Examination, Medical, Battery Powered _(verified: each item appears in the quote below)_
- **Product:** DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT | DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510K | Class II device without a valid 510K _(verified: each item appears in the quote below)_

## 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

## 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/).