SMILDEN BIOTECHNOLOGY CO., LTD.

FDA Device Registration & Listing · New Taipei City, TW · Registration 3011500388

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011500388
FEI Number
3011500388
Entity Name
SMILDEN BIOTECHNOLOGY CO., LTD.
City/State/Country
New Taipei City, TW
Establishment Address
7F, NO.186, Jian 1st Rd.,, Chung Ho District, New Taipei City 23553, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Smilden Biotechnology CO., Ltd. (Owner Number: 10091129)
Owner / Operator Contact Address
7F, NO.186, Jian 1st Rd.,, Chung Ho District, New Taipei City, TW-NWT 23553, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Aoralscan 2, Aoralscan 3 Bluem tooth brush Restoration, Resin, Crown and Bridge Dentures, Full Alloy, Metal, Base PERFIT Denture, Plastic, Teeth Retainer Alloy, gold-based noble metal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2024-12-16
EFW Toothbrush, Manual Dental Class 1 872.6855 2026-03-05
NSN Restoration, Resin, Crown And Bridge Unknown Class N N/A 2024-07-09
NSL Dentures, Full Unknown Class N N/A 2024-07-09
EJH Alloy, Metal, Base Dental Class 2 872.3710 2024-07-09
ELW Material, Impression Dental Class 2 872.3660 2024-12-16
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2024-07-09
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2024-12-16
EJT Alloy, Gold-Based Noble Metal Dental Class 2 872.3060 2024-07-09

Official Correspondent

Luisa Sam

US Agent Details

Luisa Sam Business: Smilden Inc Email: smildeninc@gmail.com Phone: (323) 7178612

Related Public Records

Same Entity

Smilden Biotechnology 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
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K810521 C.Vaupel Dental, Inc. CO-SPAN 13.5 CASTING ALLOY 1981-03-17
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11
K915276 Nobelpharma USA, Inc. DENTURE PLASTIC TEETH,76 ELM 1992-02-03

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3035512103 SHENZHEN SHUHE TECHNOLOGY CO., LTD Shenzhen Guangdong, CN
3044905014 FUSSEN IMAGING CO.,LTD. Shenzhen Guangdong, CN
3010158379 DOF INC Seoul, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011500388. Last updated year: 2026. Please use registration number 3011500388 when referencing this establishment in official correspondence.
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