Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009551666

FEI Number

3009551666

Entity Name

SURGIDENT CO., LTD.

City/State/Country

Dong-gu Daegu, KR

Establishment Address

1F, 2F, 423-7 Hyeoksin-daero, Dong-gu Daegu 41071, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Surgident Co., Ltd. (Owner Number: 10056549)

Owner / Operator Contact Address

1F, 2F, 423-7 Hyeoksin-daero, Dong-gu, KR-27 41071, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SD Abutment Pilot Drill Dental Bur NLBC Drill NLBC Stopper SD Bone Profiler SERENITI Mallet Tac Applicator Driver Handle Tac Remover Driver Dr. Sam Lee Basic set FIXTURE&SCREW REMOVER KIT TOP SYSTEM SD-TORQUE BONE MILL TOCA KIT IMPLANT PROSTHETIC DRIVER KIT EASY SINUS KIT STOP DRILL KIT TOLA KIT II Dr. Sam Lee 3 in 1 kit AQUA TOCA KIT OSTEOTOME S-SET FIXTURE REMOVER KIT Trephine Bur Assortment P.R.F SYSTEM Implant Prosthetic Driver Assortment SD-TORQUELESS MP20 RIDGE SPLIT SET Pre-Expansion Assortment IMPLANT POSITIONING KIT SD Abutment- Analog BONE MULTI SYSTEM SINGLE-OUT Tissue Punch Assortment OSTEOTOME R-SET BASIC KIT TRIMMER KIT C&L SINUS KIT NEVER LOSS BONE COLLECTOR SCREW REMOVER KIT LATERAL WALL SINUS KIT TOLA KIT Surgical Guide Kit -ZM SD Abutment - Impression Coping SD REAMER SET BONE SPREADING KIT 3S SET SD Abutment - Abutment Screw Driver Digital Sinus Guide Kit WATER RISING SYSTEM P.R.P-MEMBRANE KIT IMPLANT CLEANING BRUSH Dr. Sam Lee Ultimate Crestal&Lateral kit BONE EXPANDER KIT POWERTOME KIT Handpiece Applicator GUIDED SURGERY KIT Crestal Sinus Lift Kit Easy Bone Expander Kit Power Easy Bone Expender Kit Implant Removal Kit Gen II Drill Stop Kit Sinus Expansion Drill Kit Ridge Expansion Kit System of Torque Driver Screw Fixation Kit Shatkin F.I.R.S.T Sinus Lift Kit Contra Torque SD-Torque1.28 IMPLANT PROSTHETIC DRIVER KIT II SAVE REMOVER KIT Fixture Driver Set GBR System SD-Screw, Bone Tac GBR System Titanium Mesh Dental operative unit&accessories DR.PARK Needle Holder DR.PARK Tissue Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-06-02
EJL	Bur, Dental	Dental	Class 1	872.3240	2017-12-20
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2020-06-02
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2017-12-20
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-12-20
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-05-29
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2018-05-29
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2017-12-20
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2026-03-09

Official Correspondent

Ju-youn Choi

US Agent Details

Huiichao LEE Email: info@smbusa.com Phone: (734) 6297552

Related Public Records

Same Entity

Surgident Co., Ltd.

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009551666. Last updated year: 2026. Please use registration number 3009551666 when referencing this establishment in official correspondence.