FDA Registration
Active
🇰🇷 South Korea
SURGIDENT CO., LTD.
Reg #: 3009551666
·
FEI: 3009551666
·
Expires 2026
Products
9
Proprietary Names
80
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SURGIDENT CO., LTD.
- Registration Number
- 3009551666
- FEI Number
- 3009551666
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1F, 2F, 423-7 Hyeoksin-daero
- City
- Dong-gu Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K173570
Owner / Operator
- Firm Name
- Surgident Co., Ltd.
- Operator Number
- 10056549
- Address
- 1F, 2F, 423-7 Hyeoksin-daero
- City
- Dong-gu
- State
- Daegu
- Postal Code
- 41071
- Country
- KR
- Correspondent
- Ju-youn Choi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-06-02 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2017-12-20 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2020-06-02 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2017-12-20 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2017-12-20 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2018-05-29 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2018-05-29 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2017-12-20 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2026-03-09 |
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
Establishment Types
Manufacture Medical Device