Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005515228

FEI Number

3005515228

Entity Name

BIOMATERIALS KOREA INC.

City/State/Country

Hanam-si Gyeonggi, KR

Establishment Address

#413 #329 #331 150, Jojeong-daero, Hanam-si Gyeonggi 0, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BIOMATERIALS KOREA INC. (Owner Number: 9080640)

Owner / Operator Contact Address

#413 #329 #331 150, Jojeong-daero, Hanam-si, KR-41 0, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 ACR 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 ACR 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2006-07-27
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2014-10-16
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2014-10-16
JEY	Plate, Bone	Dental	Class 2	872.4760	2012-12-20
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2005-12-15
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2014-10-16
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2016-04-27
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2006-07-27
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2006-07-27
EJL	Bur, Dental	Dental	Class 1	872.3240	2014-10-16
EJY	Pliers, Operative	Dental	Class 1	872.4565	2014-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

BIOMATERIALS KOREA INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005515228. Last updated year: 2026. Please use registration number 3005515228 when referencing this establishment in official correspondence.