Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043303267

FEI Number

3043303267

Entity Name

ONE DAY DENTAL PARTNER

City/State/Country

Suncheon-si Jeonnam, KR

Establishment Address

9, Yeonhyang-sangga 5-gil, Suncheon-si, 2F, Suncheon-si Jeonnam 52129, KR

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

one day dental partner (Owner Number: 10095050)

Owner / Operator Contact Address

9, Yeonhyang-sangga 5-gil, Suncheon-si, 2F, Suncheon-si, KR-46 52129, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

kage Cleanser, denture, prescription kage cleanser kage Denture, plastic, teeth,print kage intraoral protect kage TEETH, ARTIFICIAL, BACKING AND FACING kagre restoration resin kage Denture preformed (partially prefabricated denture) kage pfm kage TRAY, IMPRESSION, PREFORMED kage Cushion, denture, over the counter kage System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations kage CROWN, PREFORMED kage RETAINER, SCREW EXPANSION, ORTHODONTIC kage Dentures, partial kage splint kage Accessories, implant, dental, endosseous kage Dentures, full kage ADHESIVE, DENTURE, KARAYA AND ETHYLENE-OXIDE HOMOPOLYMER kage ADHESIVE, DENTURE, KARAYA kage Radiology dental tray kage reliner, denturem over the counter kage ortho kage INSTRUMENT, DIAMOND, DENTAL kage Pad, denture, over the counter kage Coating, denture hydrophilic, resin kage crown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUX	Cleanser, Denture, Prescription	Dental	Class 1	872.3520	2026-01-21
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2026-01-21
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2026-01-21
PFL	Intraoral, Dental Foam Protector	Dental	Class 1	872.6890	2026-01-21
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2026-01-21
NSM	Restoration, Resin	Unknown	Class N	N/A	2026-01-21
EKO	Denture Preformed (Partially Prefabricated Denture)	Dental	Class 2	872.3600	2026-01-21
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2026-01-21
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2026-01-21
EHS	Cushion, Denture, Over The Counter	Dental	Class 2	872.3540	2026-01-21
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2026-01-21
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2026-01-21
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-01-21
NSK	Dentures, Partial	Unknown	Class N	N/A	2026-01-21
ELS	Splint, Endodontic Stabilizing	Dental	Class 2	872.3890	2026-01-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-01-21
NSL	Dentures, Full	Unknown	Class N	N/A	2026-01-21
KXX	Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer	Dental	Class 1	872.3450	2026-01-21
KOP	Adhesive, Denture, Karaya	Dental	Class 1	872.3450	2026-01-21
OIK	Radiology Dental Tray	Radiology	Class 2	892.1650	2026-01-21
EBP	Reliner, Denture, Over The Counter	Dental	Class 2	872.3560	2026-01-21
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2026-01-23
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2026-01-21
EHR	Pad, Denture, Over The Counter	Dental	Class 2	872.3540	2026-01-21
EBE	Coating, Denture Hydrophilic, Resin	Dental	Class 2	872.3300	2026-01-21
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2026-01-23

Official Correspondent

GYEONGHOON KOH

US Agent Details

GYEONGHOON KOH Email: kkh556465@gmail.com Phone: (214) 6296957

Related Public Records

Same Entity

one day dental partner

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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043303267. Last updated year: 2026. Please use registration number 3043303267 when referencing this establishment in official correspondence.