FDA Registration
Active
🇰🇷 South Korea
DENTAL STUDIO
Reg #: 3013547731
·
FEI: 3013547731
·
Expires 2026
Products
27
Proprietary Names
153
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- DENTAL STUDIO
- Registration Number
- 3013547731
- FEI Number
- 3013547731
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- B101, B102, B125, B1, Geumjeong Station 2nd SKV1 Tower, 136 LS-ro, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Dental Studio
- Operator Number
- 10054824
- Address
- B101, B102, B125, B1, Geumjeong Station 2nd SKV1 Tower, 136 LS-ro, Dongan-gu,
- City
- Anyang-si
- State
- Gyeonggi
- Postal Code
- 14118
- Country
- KR
- Correspondent
- Kim Beom Jun
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Explorer, Operative | EKB | Class 1 | Dental | No | 2017-05-02 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2017-05-02 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2017-05-02 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2017-05-02 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2019-11-18 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2025-12-12 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2025-12-12 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2022-07-04 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2023-04-16 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2017-05-02 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2017-05-02 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2023-04-16 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2023-04-16 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2017-05-02 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2017-05-02 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2023-04-16 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2017-05-02 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2017-05-02 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2023-04-16 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2017-05-02 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2023-04-16 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2017-05-02 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2017-05-02 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-05-02 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2023-04-16 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2017-05-02 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2023-04-16 |
Proprietary Names
PROBE
APF2-Explorer
Castroviejo scissor
Iris scissor
Micro Suture Scissors
Kelly scissor
Lagrange scissor
Dean scissor
Crown & Gold scissor
Locklin scissor
Goldman-fox scissor
Crown gauge
Implant gauge
Castroviejo calliper
Oban knife
New Easy Blade Holder
EASY BLADE HOLDER
Mess Holder
Kirkland Knife
EASY IRRIGATION TUBE
Smart Flow Precision Syringe
NSI Buddy
Implant Remover Screw [M]
Implant Remover Screw [S]
Implant Remover Screw [L]
AMALGAM BURNISHERS
AMALGAM PLUGGERS
COMPOSIT INSTRUMENTS
STOPPING STOPPER
DS-Saw
Sickle Scalers
RUBBER DAM PUNCH
RUBBER DAM FORCEPS
AMALGAM CARRIERS
TITANIUM SUCTION SET A TYPE
TITANIUM SUCTION SET B TYPE
Easy Surgical 360 Suction
APF2-Mouth gag
ROOT CANAL PLUGGERS
CORD PACKERS
Mallet 16
Surgical curette
Chisel
Excavator
EASY WINDOW SINUS CURETTE
Titanium curettes
SINUS CURETTE
Bone file
Gracey curette
WINDOW SINUS CURETTE (5SET)
ALGINATE SPATULAS
PRF BOX
EZ EXTRACTION PACKAGE A TYPE
Micro Bone Scraper
IMPLANT & SCREW REMOVER KIT(S)
SCREW DRIVER HOLDER KIT
TREPHINE GUIDE KIT
SIS Fixture Remover Kit
IMPLANT & CROWN GUIDE KIT(S)
BONE EXPANDER KIT(A)
BONE TRIMMER KIT
ABUTMENT ALIGNMENT PIN KIT (AAP KIT)
SINUS LATERAL APPROACH KIT
IMPLANT REMOVER KIT(S)
BONE EXPANDER KIT
TITANIUM BRUSH KIT(A)
SINUS COMBINATION KIT(SINUS CRESTAL KIT & LATERAL KIT)
SIMPLE SCREW REMOVER KIT
EZ EXTRACTION PACKAGE B TYPE
OSTEOTOME SET
EASY CROWN INLAY & ONLAY REMOVER KIT
AERO DRILL KIT
Hybrid Elevator SET
EZ EXTRACTION PACKAGE D TYPE
BONE PREP SURGICAL KIT
INCISOR & SEPTUM TRIMMER KIT
TREPHINE SET (ELI KIT)
Bone well
SIS Fixture Guide Kit
SINUS CRESTAL APPROACH KIT
SOFT TISSUE TRIMMER
EASY BONE SCRAPER
SINUS COMBINATION KIT (S)
EZ Extraction Package
SURGERY BASIC INSTRUMENT KIT
TISSUE PUNCH SET
TUNNELING TECHNIQUE BASIC KIT
AQUA SINUS LIFT KIT
Bone Scraper
Easy Tissue Scraper
EASY EXTRACTION BASIC KIT
IMPLANT & CROWN GUIDE KIT
Easy Implant Guide KIT
SURGICAL PACKAGE
SIMPLE SINUS CRESTAL REAMMER KIT
IMPLANT REMOVER KIT
EASY SCREW RETRIEVER KIT
SIS Bone Expander Kit
STARTer KIT
DMZ KIT
SIS Screw Remover Kit
ONE SELF BONE COLLECTOR KIT_Type A(OSBC KIT)
OSSEO-SCRAPE
NOVA Sinus Kit
PIN GUIDE KIT
MASTER KIT
TITANIUM BRUSH KIT(B)
SIMPLE SINUS LATERAL REAMMER KIT
EASY BONE SCRAPER(N)
ONE SELF BONE COLLECTOR KIT_Type B(OSBC KIT)
BONE EXPANDER KIT(B)
RUBBER DAM FRAME
Periosteal Elevator
Easy Lux
Root elevator
Root Picker
Easy Twist
Easy Periotome
Periotome
Dual Edge Elevator
Hybrid Elevator
Mirror & Holder
Root Splinter
Castroviejo needle holder
Crown Forceps
Pincette / Wide pincette
EASY ADVANCED T.P SET
CROWN REMOVER
Rongeur
Articurator holder
Extraction Forceps
CROWN OPPNER
NEEDLE HOLDER
Hemostats
EASY CROWN REMOVER PLIER
CROWN GRIPPER
Pincette / Lockking pincette
Root forceps
Endo Locking Pincette
Easy forceps
Towel clamp
Pincette / General pincette
Tissue forceps
STERILIZING FORCEPS
Tissue nipper
Wide Pincette
Pedodontic Forceps
MILLER 1X
MILLER 21
Langenbeck Retractor
Midledorpt Retractor
Minnesota Retractor
MATRIX RETAINER
Establishment Types
Manufacture Medical Device