Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038632739

FEI Number

3038632739

Entity Name

TF NEW MATERIAL SCI AND TEC CO.,LTD

City/State/Country

Huainan Anhui, CN

Establishment Address

Building 57, Xinqiao Jiahai Intelligent Manufacturing Industrial Park, Xinqiao International Industrial Park, Shouxian County, Huainan Anhui 230000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TF NEW MATERIAL SCI AND TEC CO.,LTD (Owner Number: 10093553)

Owner / Operator Contact Address

Building 57, Xinqiao Jiahai Intelligent Manufacturing Industrial Park, Xinqiao International Industrial Park, Shouxian County, Huainan, CN-AH 230000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental mirror Cotton rolls Bib Holder Rubber dam Dental kit Underpad Shoe Covers Urine bag Bed sheet rolls Rest cover Dental Curved Syringes Surgical gown Stethoscope Infusion set Articulating Paper Oxygen mask Nebulizor tube and mask Face Mask Doctor Cap Bouffant Cap micro-brushes brush applicators Alcohol Pad Surgical kit Impression general dental tray Face Shield Non-woven fabrics Composite non-woven fabrics Coated paper Crepe paper Massage Table Paper bag Dental Wedges IDEN tape Impression gun Sleeves Mixing tips Carbon Burs Sani tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2025-06-03
EFN	Cotton, Roll	Dental	Class 1	872.6050	2025-06-03
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-06-03
EIE	Dam, Rubber	Dental	Class 1	872.6300	2025-06-03
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2025-06-03
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2025-06-03
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2025-06-03
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-06-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-06-03
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2026-01-04
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-06-03
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2025-06-03
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-06-03
EFH	Paper, Articulation	Dental	Class 1	872.6140	2025-06-03
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2025-06-03
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2025-06-03
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-06-03
KXR	Applicator, Resin	Dental	Class 1	872.3140	2025-06-03
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-06-03
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-06-03
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2025-06-03
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2025-06-03
FFF	Cover, Biopsy Forceps	Gastroenterology, Urology	Class 1	876.1075	2025-06-03
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-06-03
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2025-06-03
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-06-03
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2025-06-03
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2025-06-03
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2025-06-03
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-06-03
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-06-03
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2025-06-03

Official Correspondent

Rebecca Meng

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

TF NEW MATERIAL SCI AND TEC 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038632739. Last updated year: 2026. Please use registration number 3038632739 when referencing this establishment in official correspondence.