FDA Registration
Active
🇰🇷 South Korea
BIOMATERIALS KOREA INC.
Reg #: 3005515228
·
FEI: 3005515228
·
Expires 2026
Products
17
Proprietary Names
315
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- BIOMATERIALS KOREA INC.
- Registration Number
- 3005515228
- FEI Number
- 3005515228
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #413 #329 #331 150, Jojeong-daero
- City
- Hanam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K110926
Owner / Operator
- Firm Name
- BIOMATERIALS KOREA INC.
- Operator Number
- 9080640
- Address
- #413 #329 #331 150, Jojeong-daero
- City
- Hanam-si
- State
- Gyeonggi
- Postal Code
- 0
- Country
- KR
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2006-07-27 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2014-10-16 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2014-10-16 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2012-12-20 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2005-12-15 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2014-10-16 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2016-04-27 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2006-07-27 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2006-07-27 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2014-10-16 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2014-10-16 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2011-11-21 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2014-10-16 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2019-11-22 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2014-10-16 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2019-06-19 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2016-04-27 |
Proprietary Names
ACR
6636
7197
4995
6937
4928
ACR-PC
6453
4815
4962
SDB-1265X1
SDB15
UEB-20C
LEB-U2(BS)
LEBC-HP
LEB-U(BS)
SEB-23C
SDB-15C-60
SDB-15C
SDB-U2(BS)
SDB-U(BS)
LEB-15C
LEBC
SDB-15C-75
SEB-SL
SDBU-C
SEB-20SQ
SDB12
SDBC-HP
SDB-20C-90
SDB-15C-82
SDB-SL
LEBO-MP
LEB-23C
SDB-20C-70
SEB-SMS
UEB-20C(11)
SDB-23C-90
SEBC
SDB-1675X1
SDBO-MP
LEB-20C
SEB-U2(BS)
SDB-SMS
SEB-U(BS)
SEB12
SEB-15C
SEBO
LEB-SMS
SDB-20C-80
LEB12
SDB-23C-60
SDBO
SEBC-HP
SDBC
LEB15
SEB15
SEB-20C
SDB-20C-C-SQ
LEBO
RDB-KBE
RDB-MSE
RPE B-10
RPE C-6
RPE C-12
RPE A-12
RPE B-6
RPE D-12
RPE C-8
MSE-12
MSE II-10 E
MSE II-12 E
MSE-11
MSE II-10 F
MSE II-6 F
MSE II-8 F
KBE II-6
MSE II-6 E
KBE II-8
MSE-10
MSE-8
MSE-6
KBE II-12
MSE II-12 F
KBE-6
KBE II-10
MSE II-8 E
KBE-8
MSE IV-6 B
MSE II-12 G
MSE IV-6 A
MSE III-6 A
MSE III-8 A
MSE III-8 B
MSE IV-8 B
MSE II-6 G
MSE III-10 A
MSE III-12 A
MSE IV-12 A
MSE II-12 H
MSE III-10 B
MSE II-8 G
MSE IV-12 B
MSE III-6 B
MSE II-10 H
MSE III-12 B
MSE II-6 H
MSE IV-10 B
MSE II-8 H
KBE-10
MSE IV-8 A
MSE II-10 G
MSE IV-10 A
KBE-12
RPE A-6
RPE B-8
RPE D-10
RPE A-10
RPE A-8
RPE D-8
RPE D-6
RPE B-12
RPE C-10
6649
ACR-HF
5341
5542
PHI Micro
PHI Mini
PHI Maxi
4054
NTM-LLS
NTU12-EE
NTM9-EE
NLT-LE
NTM9-EH
NTH12-EE
NTL-LLS
NTU9-EE
NTL12-EE
NTU-LES
NTL-LHS
NYU12-EH
NTU-LH
NTM12-EH
NTH-LH
NTH9-EH
NTU-LE
NTU-LLS
NTU-LL
NTM-LHS
NTH9-EE
NLT-LES
NTH-LL
NTH-LHS
NTL12-EH
NTH12-EH
NTL-LH
NTH-LLS
NTM-LES
NTL-LL
NTU9-EH
NTM-LH
NTU-LHS
NTM-LL
NTM12-EE
NTM-LE
NLT9-EH
NTH-LE
NTH-LES
NTL9-EE
SDH2
SDH4
MHDC-HP
SDH1
SDH3
MHD12
MHD-SMS
MHDC
MHDO
MHD15
MHD-Y
RW
OSD-1650-07S
OSD-1470-14S (1.37mm)
OSD-1150-15S
OSD-1465-07S
OSD-1622-09C
OSD-16125-21S
OSD-12105-14S
OSD-1270-09S
OSD-1670-09S
OSD-1370-20S
OSD-1265-07S
OSD-1050-07S
OSD-1620-07C
OSD-11105-21S
OSD-1470-26
OSD-1270-07S
OSD-1670-14S
OSD-1625-12C
OSD-1633-14C
OSD-1070-12S
OSD-1826-07C
OSD-1665-07S
OSD-1570-20S
OSD-1470-14S
OSD-1270-14S
OSD-1828-09C
OSD-1550-20S
OSD-18105-14S
OSD-1550-11S
OSD-1670-07S
OSD-1824-05C
OSD-1870-20S (1.85mm)
OSD-1450-07S
OSD-16105-21S
OSD-1660-22S
OSD-1465-05S
OSD-1370-14S
OSD-1062-06S
OSD-18105-25S
OSD-16105-23S
OSD-1231-12C
OSD-1844-25C
OSD-1415-05C (1.34mm)
OSD-19105-07S
OSD-19115-15S
OSD-15115-11S
OSD-1228-09C
OSD-1325-11C
OSD-1662-06S
OSD-1070-14S
OSD-1034-12C
OSD-1870-07S (1.85mm)
OSD-16105-14S
OSD-18105-07S
OSD-1670-05S
OSD-1434-04C
5022
4986
6105
4668
6251
4191
ACR-MP
4982
4984
4433
5019
4670
4987
OAS-T1809-SP
OAS-T1813-SP
OAS-T1811-SP
6668
4309
6584
PreOrtho Type3-LH
PreOrtho Initial
PreOrtho Type3-SH
PreOrtho Type3-SS
PreOrtho Type1-SS
PreOrtho Type3-LS
Pre-Ortho Type1-LH
PreOrtho Type2-MH
PreOrtho Type3-MS
PreOrtho Type1-MS
PreOrtho Type2-MS
PreOrtho Type1-SH
PreOrtho Type1-LS
PreOrtho Type1-MH
PreOrtho Type3-MH
4809
SR-4038
SR-4060-D5
SR-4060-D6
SO-1360
SO-2060
SO-1538
SR-4060-Z
SO-1560
SR-4060-D7
SR-2738
SR-4060-D4
MS saw(Right)-S
SR-3238
B0-5050
SO-0860-G2
SO-0860-G4
SO-1838
S MS saw(Left)-S
SR-4060-D2
SR-4060-D3
SP-3409
SO-1338
SR-1438
MS saw(Right)-A
SR-4060
MS saw(Left)-A
SO-0860-G5
SO-1860
SR-4038-Z
SO-0860-G1
SR-4038-AR
B0-3055
SO-0860
SO-0860-G3
DISCOpender 6.5
DISCOpender 6.5X
DISCOpender 468
DISCOpender 2.8
DISCOpender 4
DISCOpender 2.8X
Anchor Plate
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device