Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006113314

FEI Number

3006113314

Entity Name

SPIDENT CO., LTD.

City/State/Country

INCHEON Gyeonggi, KR

Establishment Address

312, 151B-6L NAMDONGGONGDAN, INCHEON Gyeonggi 405-821, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPIDENT CO., LTD. (Owner Number: 9089446)

Owner / Operator Contact Address

312, 151B-6L NAMDONGGONGDAN, --, INCHEON, KR-NOTA 405-821, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SoftPrep EsCom250 Temp.ro, Temp.ro Flow K-Bond Universal Bonding Agent FineDam BLooming Masks EsTemp Implant EsFlow PLUS VioSeal Core It Dual FOCUS EsTemp NE EsBond Spident Bite Tray EsCem Resin Cement Base It EsCem RMGI Resin-Modified Glass Ionomer Cement EsFlow Seal it Magnificent Flowable Composite BLooming Gloves PAPAER POINTS Absorbent Paper Accessory Points Paper Point Block-Out Resin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2012-02-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-08-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2024-07-30
EIE	Dam, Rubber	Dental	Class 1	872.6300	2012-02-17
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2012-04-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-05-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-06-01
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-11-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2012-04-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2012-05-29
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2012-04-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-01-04
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2016-05-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-06-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-05-29
FMC	Patient Examination Glove	General Hospital	Class 1	880.6250	2012-04-19
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2006-07-06
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2020-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

SPIDENT 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3043655586	FOSHAN ORECK MEDICAL TECHNOLOGY CO.,LTD	Foshan City Guangdong, CN
2436986	META DENTAL CORP.	Glendale, NY, US
8030962	Micro-Mega SA	BESANCON Doubs, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006113314. Last updated year: 2026. Please use registration number 3006113314 when referencing this establishment in official correspondence.