# Creative Concepts Manufacturing Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Creative Concepts Manufacturing 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 UV Toothbrush Sanitizer | UV Toothbrush Sanitizer; product code is 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile | 80 K - - YZ Syringe, Irrigating; date published is 03/11/2015; address is 1210-c 12/f Harbour Center Tower 1 , 1 Hok Cheung Street Hung Hom , Kowloon, CHINA, verified against its source on 2026-09-16.

- **Firm:** Creative Concepts Manufacturing 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:** 1210-c 12/f Harbour Center Tower 1 , 1 Hok Cheung Street Hung Hom , Kowloon, CHINA _(verified: appears in the quote below)_
- **Date published:** 03/11/2015 _(verified: appears in the quote below)_
- **Product code:** 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile | 80 K - - YZ Syringe, Irrigating _(verified: each item appears in the quote below)_
- **Product:** UV Toothbrush Sanitizer | UV Toothbrush Sanitizer _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Creative Concepts Manufacturing Ltd. Date Published : 03/11/2015 1210-c 12/f Harbour Center Tower 1 , 1 Hok Cheung Street Hung Hom , Kowloon, CHINA 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile Date Published: 03/11/2015 Desc: UV Toothbrush Sanitizer Notes: Class II 80 K - - YZ Syringe, Irrigating Date Published: 03/11/2015 Desc: UV Toothbrush Sanitizer Notes: Class II

## 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/).