# Biomaterials Korea Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Biomaterials Korea Inc. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Maxillary Skeletal Expander (MSE); product code is 76 D - - YJ Retainer, Screw Expansion, Orthodontic; date published is 11/13/2025; address is #413 #329 #331 150 , Jojeong-daero Hanam-si , Gyeonggido, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Biomaterials Korea Inc. _(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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** #413 #329 #331 150 , Jojeong-daero Hanam-si , Gyeonggido, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/13/2025 _(verified: appears in the quote below)_
- **Product code:** 76 D - - YJ Retainer, Screw Expansion, Orthodontic _(verified: appears in the quote below)_
- **Product:** Maxillary Skeletal Expander (MSE) _(verified: appears in the quote below)_

## What the source says

> Biomaterials Korea Inc. Date Published : 11/13/2025 #413 #329 #331 150 , Jojeong-daero Hanam-si , Gyeonggido, KOREA (THE REPUBLIC OF) 76 D - - YJ Retainer, Screw Expansion, Orthodontic Date Published: 11/13/2025 Desc: Maxillary Skeletal Expander (MSE)

## 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/).