Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008320092

FEI Number

3008320092

Entity Name

Shandong Huge Dental Material Corporation

City/State/Country

Rizhao Shandong, CN

Establishment Address

No. 68 Shanhai Road, Donggang District, Rizhao Shandong 276800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Huge Dental Material Corporation (Owner Number: 10031883)

Owner / Operator Contact Address

No. 68 Shanhai Road, Donggang District, Rizhao, CN-SD 276800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260376

PMA Number

N/A

All Registered Proprietary Names

Flexible Block Synthetic Polymer Teeth KAIJING Seniors IMPLA NOBILDENT KAILI KAIBIAO (MAIST) KAIFENG (Sonning) KAITONG (Bluebell) KAIPLUS Select XL Prime DXL Elastomeric Impression Material Casting Wax Firing Paste Oral tips Dispenser Dispensing gun Mixer Mixing tips Mixer & Oral tips BioTemps NOW Milling Blocks PMMA BLOCK Light Curing Tray Upper tray Impression Tray Lower tray Impression Tray Lower tray Upper tray Light Curing Tray Dental Model Wonder Light Cure Tray Tray Adhesive Glass Ionomer Cement (Luting) Glass Ionomer Cement Eternal Art Porcelain Powders Eternal Art Stain&Glaze Porcelain Powders Try-in Denture Base Polymers A-Silicone for Bite Registration Surgical Guide PERFIT Ear Impression Silicone TopCEM Dual Cure Resin Cement UltraCore Dual Cure Resin Cement VinciSmile Invisible Orthodontic Appliance Denture Base

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2022-04-07
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-04-07
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2010-08-18
ELW	Material, Impression	Dental	Class 2	872.3660	2014-05-30
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2010-03-17
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2025-09-10
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2017-02-16
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-09-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2013-06-27
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2017-12-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-11-08
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2026-04-14
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2025-06-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-08-12
ELW	Material, Impression	Dental	Class 2	872.3660	2020-09-24
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-04-03
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2025-08-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-12-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-12-25
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2019-04-18
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2026-05-11

Official Correspondent

Steven Song

US Agent Details

Xin Song Email: marketing@vincismile.com Phone: (626) 2835808

Related Public Records

Same Entity

Shandong Huge Dental Material Corporation

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008320092. Last updated year: 2026. Please use registration number 3008320092 when referencing this establishment in official correspondence.