Biomaterials Korea Inc. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- #413 #329 #331 150 , Jojeong-daero Hanam-si , Gyeonggido, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/13/2025 verified
- Product code
- 76 D - - YJ Retainer, Screw Expansion, Orthodontic verified
- Product
- Maxillary Skeletal Expander (MSE) verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.