Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038715999

FEI Number

3038715999

Entity Name

SMD DENTAL LABORATORY

City/State/Country

Heungdeok-gu Cheongju-si Chungbuk, KR

Establishment Address

5, Jimdae-ro 72beon-gil, Heungdeok-gu Cheongju-si Chungbuk 28579, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SMD Dental Laboratory (Owner Number: 10094247)

Owner / Operator Contact Address

5, Jimdae-ro 72beon-gil, Heungdeok-gu Cheongju-si, KR-43 28579, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Emax Inlay/Onlay Zirconia Crown Emax Crown Emax Veneer Dentures, Full Noble Crown Custom Abutment LUXEN Zr, LUXEN Smile orthodontic retainer Full Metal Crown impression tray Accessories, Implant, Dental, Endosseous

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2025-12-31
NSL	Dentures, Full	Unknown	Class N	N/A	2025-12-31
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2025-12-31
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-11-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-25
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-03-25
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2025-12-31
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2026-03-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-12-31

Official Correspondent

Man Young Bae

US Agent Details

Van Bui Business: B2 Solutions, LLC Email: van@b2solutions.org Phone: (206) 2148570

Related Public Records

Same Entity

SMD Dental Laboratory

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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

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.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
3021389380	ABL DENTAL SOLUTIONS S.A.S	Envigado Antioquia, CO
3005310881	DIGITAL DENTAL FUSION KOREA	Seoul, KR
3021241833	LEAGUE DENTAL TECHNOLOGY LTD	Shenzhen Guangdong, CN
3005952241	ACER DENTALLAB CO LIMITED	HONGKONG, HK
3007268434	ADS DENTAL LAB LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038715999. Last updated year: 2026. Please use registration number 3038715999 when referencing this establishment in official correspondence.