Data / Medical devices / South Korea / SMD Dental Laboratory

SMD Dental Laboratory: FDA-registered device maker in Heungdeok-gu Cheongju-si Chungbuk, South Korea, 3 510(k) clearances

Name: SMD Dental Laboratory FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SMD Dental Laboratory is registered with the FDA (registration 3038715999) in Heungdeok-gu Cheongju-si Chungbuk, South Korea. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3038715999
Address: 5, Jimdae-ro 72beon-gil, Heungdeok-gu Cheongju-si Chungbuk, South Korea, 28579
Owner or operator: SMD Dental Laboratory (10094247)
Roles: Contract manufacturer, Manufacturer
First device listed: November 20, 2025
Registered through: 2027
Brand names listed: Accessories, Implant, Dental, Endosseous, Custom Abutment, Custom Abutments, Dentures, Full, Emax Crown, Emax Inlay/Onlay, Emax Veneer, Full Metal Crown and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Dentures, Full	NSL	N	Manufacturer	accessdata.fda.gov
Dentures, Partial	NSK	N	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Contract manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov
Restoration, Base Metal	NSQ	N	Manufacturer	accessdata.fda.gov
Restoration, Noble Metal	NSJ	N	Manufacturer	accessdata.fda.gov
Restoration, Porcelain	NSP	N	Manufacturer	accessdata.fda.gov
Restoration, Porcelain-Fused-To-Metal	NSO	N	Manufacturer	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Teeth, Artificial, Posterior With Metal Insert	ELJ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 21, 2025	K243278	Custom Abutments	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
October 31, 2018	K171585	LUXEN Zr, LUXEN Smile	EIH	Substantially Equivalent	Dentalmax Co., Ltd.	accessdata.fda.gov
September 15, 2016	K160828	Dentium Implantium & SuperLine Prosthetics	NHA	Substantially Equivalent	Dentium Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.