Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010896988

FEI Number

3010896988

Entity Name

ATRIA Co.

City/State/Country

Seoul, KR

Establishment Address

A-#710, Seoulsup SK V1 Tower, 5, Seongsuil-ro 8-gil, Seongdong-gu,, Seoul 133833, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Atria Co. (Owner Number: 10046598)

Owner / Operator Contact Address

A-#701-712, Seoulsup SK V1 Tower, 5,, Seongsuil-ro 8-gil, Seongdong-gu,, Seoul, KR-11 04793, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria Atria A-Sleeve EZ Drape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-11-25
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-11-25
JES	Floss, Dental	Dental	Class 1	872.6390	2014-04-11
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2015-11-25
FHH	Crusher, Spur, Colostomy	Gastroenterology, Urology	Class 1	876.4730	2015-11-25
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2014-04-11
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-07-19
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-11-07
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2014-04-11
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2024-11-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-04-11
EIS	Remover, Crown	Dental	Class 1	872.4565	2024-11-07
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-07-19
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2015-11-25
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-11-07
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2014-04-11

Official Correspondent

Jae Young Kim

US Agent Details

Vera Au Business: Applied Dental, Incorporated Email: vera@AD-Surgical.com Phone: (408) 7248832

Related Public Records

Same Entity

Atria Co.

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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

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 3010896988. Last updated year: 2026. Please use registration number 3010896988 when referencing this establishment in official correspondence.