Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021964955

FEI Number

3021964955

Entity Name

DTS DIGITAL DENTAL LAB

City/State/Country

shenzhen Guangdong, CN

Establishment Address

8C Kangtaijian dental factory No.7 Rongtian road Jinsha community kengzi, Pingshan area shenzhen, shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DTS Digital Dental Lab (Owner Number: 10084206)

Owner / Operator Contact Address

8C Kangtaijian dental factory No.7 Rongtian road Jinsha community kengzi, Pingshan area shenzhen, shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EMAX Crown / Bridge; Full Ceramic Restoration; Porcelain Restoration; Zirconia Crown / Bridge Dess Dental Smart Solution RETAINER, SCREW EXPANSION, ORTHODONTIC Dess Dental Smart Solution Metal Restoration (Noble Metal / Semi Precious Metal/ Base Metal) Surgical Guide KTJ Scanbody multi-use WYSM KTJ Scanbody H6/H8/H10 KTJ Lab Analog NTD/WTD KTJ Lab screw M1.2/M1.4/M1.6/M1.8/M2 Dess Dental Smart Solution Dess Dental Smart Solution FLEXIBLE DENTURE; PARTIAL DENTURE; REMOVABLE PARTIAL DENTURE Porcelain Fused to Metal Restoration Dess Dental Smart Solution Mouthguard; Nightguard; Orthodontic Appliance; Retainer; Screw Appliance ACRYLIC DENTURE; FULL DENTURE; IMMEDIATE DENTURE;COVERDENTURE DENTURE ; OVERDENTURE DENTURE COMPOSITE RESIN CROWN AND BRIDGE; TEMPORARY CROWN AND BRIDGE Dess Dental Smart Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2022-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-01-26
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2022-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2022-01-26
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-01-26
NSK	Dentures, Partial	Unknown	Class N	N/A	2022-01-26
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2022-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2022-01-26
NSL	Dentures, Full	Unknown	Class N	N/A	2022-01-26
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2022-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-01-26

Official Correspondent

Julia Yang

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

DTS Digital Dental Lab

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3021389380	ABL DENTAL SOLUTIONS S.A.S	Envigado Antioquia, CO
3005310881	DIGITAL DENTAL FUSION KOREA	Seoul, KR
3021241833	LEAGUE DENTAL TECHNOLOGY LTD	Shenzhen Guangdong, CN
3005952241	ACER DENTALLAB CO LIMITED	HONGKONG, HK
3007268434	ADS DENTAL LAB LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021964955. Last updated year: 2026. Please use registration number 3021964955 when referencing this establishment in official correspondence.