Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017674095

FEI Number

3017674095

Entity Name

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

City/State/Country

Rizhao Shandong, CN

Establishment Address

No.2 North Zhaoyang Road, District of Donggang, Rizhao Shandong 276800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rizhao HuGe Biomaterials Company, Ltd. (Owner Number: 10078492)

Owner / Operator Contact Address

No.2 North Zhaoyang Road, District of Donggang, Rizhao, CN-SD 276800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241204

PMA Number

N/A

All Registered Proprietary Names

TopCEM Dual Cure Resin Cement UltraCore Dual Cure Resin Cement Dual Cure Resin Cement TopCEM-Try in Veneer Try-in Gel Light Cure Dental Adhesive Phosphoric Acid Etching Gel TopCEM Vigor SA Self-Adhesive Resin Cement TrusFIL-Flow Flowable Composite Restorative Proseal Enamel Coating Resin TopCEM-Veneer Light Cure Veneer Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-07-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2024-07-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-10-23
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-10-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-12-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-10-23
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-10-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-12-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-10-27
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2023-07-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-06-30
EMA	Cement, Dental	Dental	Class 2	872.3275	2024-06-30

Official Correspondent

Maggie Zheng

US Agent Details

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

Related Public Records

Same Entity

Rizhao HuGe Biomaterials Company, 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017674095. Last updated year: 2026. Please use registration number 3017674095 when referencing this establishment in official correspondence.