Biomaterials Korea Inc.
Hanam-si Gyeonggi, KR
BIOMATERIALS KOREA INC. appears in FDA device records in Hanam-si Gyeonggi, KR. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Biomaterials Korea Inc. between 2007 and 2023. The busiest year on record is 2011, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2011 | 2 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222245 | ACR Screw System | OAT | Substantially Equivalent | |
| K173623 | Anchor plate | OAT | Substantially Equivalent | |
| K110926 | BONE PLATE; BONE SCREW | JEY | Substantially Equivalent | |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | OAT | Substantially Equivalent | |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | OAT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005515228 | 3005515228 | BIOMATERIALS KOREA INC. | #413 #329 #331 150, Jojeong-daero, Hanam-si Gyeonggi 0 KR | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- DYOBand, Material, Orthodontic
- EJLBur, Dental
- ECNClamp, Wire, Orthodontic
- ECTDriver, Band, Orthodontic
- EMHForceps, Rongeur, Surgical
- EJBHandle, Instrument, Dental
- OATImplant, Endosseous, Orthodontic
- EKDInstrument, Cutting, Operative
- JEYPlate, Bone
- EJYPliers, Operative
- KMYPositioner, Tooth, Preformed
- EIXProbe, Periodontic
- DYJRetainer, Screw Expansion, Orthodontic
- EGNScissors, Surgical Tissue, Dental
- ECOSpring, Orthodontic
- DZCWire, Orthodontic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain