Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008388427

FEI Number

3008388427

Entity Name

MCTBIO

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

46 Chobu-ro, Mohyeon-myeon, Cheoin-gu, Yongin-si Gyeonggi 17037, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MCTBIO (Owner Number: 10032614)

Owner / Operator Contact Address

46 Chobu-ro, Mohyeon-myeon, Cheoin-gu, Yongin-si, KR-41 17037, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENTAL IMPLANT DRILL Bone Rongeur/ Forcep/ Retractor BONE TAC ORTHODONTIC SCREW SMART MIXER SCALE/Excavator Periotome/ Peiosteal Elevator/ Bone Curette/Gracey Curette/Scaler SCISSORS SPLIT & SINUS MASTER BONE EXPANDER ACCESSORIES, IMPLANT MASAI DRILL PREMIUM RIDGE SPLIT KIT GOLD MILL Screw Remover Fixture Remover AQUA SYSTEM BONE CREST MASTER SPLIT & SINUS MASTER New Bone Chip Maker INSTRUMENT/ DENTAL STAR JECT ENDO STAR JECT IRRIGATION SYSTEM Mallet MIRROR/ Mouth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2012-07-12
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-05-31
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2014-02-12
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-07-12
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2010-05-31
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2010-05-31
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-05-31
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-05-31
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2010-05-31
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2010-05-31
DZM	Needle, Dental	Dental	Class 1	872.4730	2017-02-08
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2010-06-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-05-31
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2010-05-31

Official Correspondent

Sungyoun Kim

US Agent Details

KEVIN Bang Business: K B DENTAL PRODUCTS Email: kevin@kbdentalusa.com Phone: (714) 5915851

Related Public Records

Same Entity

MCTBIO

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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 3008388427. Last updated year: 2026. Please use registration number 3008388427 when referencing this establishment in official correspondence.