Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009420946

FEI Number

3009420946

Entity Name

HUANGHUA PROMISEE DENTAL CO., LTD

City/State/Country

Huanghua Hebei, CN

Establishment Address

Kangtian Road, Longchuang Industrial Park, Huanghua Hebei 061100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huanghua Promisee Dental Co., Ltd (Owner Number: 10038868)

Owner / Operator Contact Address

Kangtian Road, Longchuang Industrial Park, Huanghua, CN-HE 061100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Micro applicator Perfect Gingival Brushes micro applicator spatula Probe Punch autoclavable instrument kit autoclavable plastic tray sterilising trays acrylic display stand Endo box Disposable plastic trays Aligner Chewies, Retainer Retrievers, Invisible Braces Box protective light hand shield Safety glasses Cotton Roll Dispenser Dental Dam Kit Wedge Floss Evacuator, Oral Cavity Dental Implant Guide Syestem Kit Toothbrush Eye Shield disposable mirrors Clamp Prophy brush Prophy cup Microdont Endo ruler root cannal measuring ruler Measuring Guage Dental Ruler aligner chewies Composite Polisher dental syringe cleanser Air water dental syringe tip Adhesive Tip Applicators 20 pieces of clearance wedges with holes in four types Adhesive tip applicator 20 pieces of resin matrix bands in both large and small size 6 pieces of clamping rings One piece of medical forceps 20 pieces of subgingival matrix bands in large size Matrix Bands Kit 20pieces of subgingival matrix bands in small size 6 pieces of silicon clearance wedges 50 pieces of ordinary matrix bands in medium size 50 pieces of ordinary matrix bands in small size 20 pieces of software clearance wedges in four types 50pieces of ordinary matrix bands in large size 20 pieces of subgingival matrix bands in medium size wedgeguards Dental Bibs hygienic liquid dispenser Compule dispenser gun compule dispenser gun Denture box Protective Shield Face Shield cotton ball cotton roll Instrument brush Universal barrier film Dental retractor Prophy Paste Disposable Fluoride Tray OTOSCOPE TIPS Smart Dental Wedges Dental Wedge 5 in 1 disposable dental kit 7 in 1 disposable dental kit 3 in 1 disposable dental kit 8 in 1 disposable dental kit rubber dam retractor mouth prop RETRACTOR clamping ring cotton roll clip dental bib clip general tray tray base Impression tray base TEETH WHITEING TRAY ADJUSTABLE IMPRESSION TRAY Autoclavable IMPRESSION tray IMPLANT TRAY Disposable IMPRESSION tray Mixing bowl Container, Liquid Medication, Graduated Adhesive Dappen Dishes aligner removal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-11-18
KXR	Applicator, Resin	Dental	Class 1	872.3140	2015-05-18
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-11-18
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2013-12-17
EIE	Dam, Rubber	Dental	Class 1	872.6300	2022-05-16
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-11-21
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2024-01-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2011-11-18
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-11-21
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2022-01-02
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2014-12-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-09-26
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-08-25
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-19
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-11-18
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2022-05-16
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2019-12-10
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2015-05-18
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2023-03-18
EHL	Point, Abrasive	Dental	Class 1	872.6010	2023-04-10
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-11-18
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2015-06-25
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2021-09-26
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2011-11-18
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2023-03-18
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2011-11-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-19
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-03-17
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2022-06-02
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2011-11-21
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2011-11-18
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-04-11
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2014-04-11
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2011-11-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-11-18
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2013-12-17
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-03-18
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2023-03-18
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-11-18
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2011-11-18
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2023-03-18

Official Correspondent

Qingxuan He

US Agent Details

Anna SUN Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Huanghua Promisee Dental 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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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 3009420946. Last updated year: 2026. Please use registration number 3009420946 when referencing this establishment in official correspondence.