Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015548849

FEI Number

3015548849

Entity Name

Changsha Easyinsmile Intelligence Technology Co.Ltd.

City/State/Country

Changsha Hunan, CN

Establishment Address

1003, Building 14,Workingdom Park,No.662 Qingshan Road,Gaoxin District, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changsha Easyinsmile Intelligence Technology Co.,Ltd. (Owner Number: 10064889)

Owner / Operator Contact Address

1003, Building 14,Workingdom Park,No.662 Qingshan Road,Gaoxin District, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Band, Material, Orthodontic Matrices Refill Sectional contoured metal Adhesive, Denture, Acacia And Karaya With Sodium Borate models X-SMALL,X-LARGE Dental Crown X-TWO-S,X-ULTRASONIC,X-BABY,X3-MAX,X-PATH,K FILE,H-FILE,R-FILE,S-FILE,C-FILE Endodontic File Models X-TAPER,G3-PRO GOLD,X-ONE,X3,X-CORN,X-PRO GOLD,X-RECIPORC,X-RETREATMENT X-root Sealer Dental cement Mouth opener Oral photodynamic therapy device ModeLight PDT 630, Light PDT B Orthodontic wire Models COLOR CODE, SS,NITI,BETA-II,COIL-I Photosensitizer Models: High, Medium, Low Orthodontic Metal Bracket models: DO-I,DO-II,DO-III,DO-IV,CNS-I,CNS-II,CNS-III,CNS-IV Easydo Activator Implant detector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2023-08-16
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2021-07-05
KOM	Adhesive, Denture, Acacia And Karaya With Sodium Borate	Dental	Class 1	872.3400	2023-08-16
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2024-02-23
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-08-16
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2023-05-25
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-07-21
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2024-02-23
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-08-16
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2024-03-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2021-08-04
JET	Pick, Massaging	Dental	Class 1	872.6650	2021-03-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-07-25

Official Correspondent

Tiran Zhang

US Agent Details

Tiran Zhang Email: 155140870@qq.com Phone: (407) 3766174

Related Public Records

Same Entity

Changsha Easyinsmile Intelligence Technology 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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 3015548849. Last updated year: 2026. Please use registration number 3015548849 when referencing this establishment in official correspondence.