Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030426160

FEI Number

3030426160

Entity Name

SIMDA CO.,LTD.

City/State/Country

Busan, KR

Establishment Address

233, Hakgam-daero, Sasang-gu, Busan, Busan 46985, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIMDA CO.,LTD. (Owner Number: 10089691)

Owner / Operator Contact Address

233, Hakgam-daero, Sasang-gu, Busan, Busan, KR-26 46985, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223663

PMA Number

N/A

All Registered Proprietary Names

Scan Body Lab Analog SIMDA Abutment Lab Analog SIMDA Abutment Scan Body SIMDA Abutment Scan Body Lab Analog

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	2025-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-28

Official Correspondent

YoungWoo CHA

US Agent Details

Charles Park Business: B&B DENTAL CERAMIC ARTS INC. DBA 3DBioCAD Email: charles.p@3dbiocad.com Phone: (206) 7153999

Related Public Records

Same Entity

SIMDA 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

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.

Similar Registrations

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030426160. Last updated year: 2026. Please use registration number 3030426160 when referencing this establishment in official correspondence.