FDA Registration Active 🇰🇷 South Korea

SMD DENTAL LABORATORY

Reg #: 3038715999 · FEI: 3038715999 · Expires 2026
Products
14
Proprietary Names
18
Establishment Types
2
Classifications
14

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Registration Details

Registration Name
SMD DENTAL LABORATORY
Registration Number
3038715999
FEI Number
3038715999
Status
Active
Expiry Year
2026
Initial Importer
No
Address
5, Jimdae-ro 72beon-gil
City
Heungdeok-gu Cheongju-si Chungbuk
Country
KR

Regulatory Submissions

510(k) Number
K160828

Owner / Operator

Firm Name
SMD Dental Laboratory
Operator Number
10094247
Address
5, Jimdae-ro 72beon-gil
City
Heungdeok-gu Cheongju-si
State
Chungbuk
Postal Code
28579
Country
KR
Correspondent
Man Young Bae

US Agent

Business Name
B2 Solutions, LLC
Contact Name
Van Bui
Address
36 Shadow Brook Ln
City
Lander
State
WY
ZIP
82520
Country
US
Phone
206 2148570

Products

Device Name Product Code
Restoration, Porcelain NSP
Dentures, Full NSL
Restoration, Noble Metal NSJ
Abutment, Implant, Dental, Endosseous NHA
Powder, Porcelain EIH
Retainer, Screw Expansion, Orthodontic DYJ
Restoration, Base Metal NSQ
Material, Impression Tray, Resin EBH
Accessories, Implant, Dental, Endosseous NDP
Material, Tooth Shade, Resin EBF
Dentures, Partial NSK
Teeth, Artificial, Posterior With Metal Insert ELJ
Restoration, Resin, Crown And Bridge NSN
Restoration, Porcelain-Fused-To-Metal NSO

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 MAZIC Duro Partial Denture TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT Restoration, Resin, Crown And Bridge Custom Abutments PFM

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)