Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013547731

FEI Number

3013547731

Entity Name

DENTAL STUDIO

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

B101, B102, B125, B1, Geumjeong Station 2nd SKV1 Tower, 136 LS-ro, Dongan-gu, Anyang-si Gyeonggi 14118, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dental Studio (Owner Number: 10054824)

Owner / Operator Contact Address

B101, B102, B125, B1, Geumjeong Station 2nd SKV1 Tower, 136 LS-ro, Dongan-gu,, Anyang-si, KR-41 14118, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKB	Explorer, Operative	Dental	Class 1	872.4565	2017-05-02
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2017-05-02
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2017-05-02
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2017-05-02
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2019-11-18
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2025-12-12
DZM	Needle, Dental	Dental	Class 1	872.4730	2025-12-12
EIS	Remover, Crown	Dental	Class 1	872.4565	2022-07-04
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2023-04-16
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2017-05-02
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2017-05-02
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2023-04-16
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2023-04-16
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2017-05-02
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2017-05-02
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2023-04-16
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2017-05-02

Official Correspondent

Kim Beom Jun

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

Dental Studio

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013547731. Last updated year: 2026. Please use registration number 3013547731 when referencing this establishment in official correspondence.