Biomaterials Korea Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Biomaterials Korea Inc., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
76 D - - YJ Retainer, Screw Expansion, Orthodontic Date Published: 11/13/2025 Desc: Maxillary Skeletal Expander (MSE)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html