Shandong Huge Dental Material Corporation
Manufacturer and brand owner in Rizhao, Shandong, China. 17 device types, 17 products catalogued, 9 clearances.
Shandong Huge Dental Material Corporation is a manufacturer holding a current FDA establishment registration. The registration covers Cement, Dental, Powder, Porcelain and 15 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
17device types registered with the FDA
17products catalogued under its own name
9510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008320092 |
| FEI number | 3008320092 |
| DUNS | 528184691 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 山东沪鸽口腔医疗集团有限公司 |
|---|---|
| Unified social credit code | 91371100796157643Q |
| Source | NMPA UDI database |
Location
| City | Rizhao |
|---|---|
| Province | Shandong |
| Address | No. 68 Shanhai Road, Donggang District |
| Postal code | 276800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Surgical Guide | 2020 | 70 |
| Aligner, Sequential | Class 2 | VinciSmile Invisible Orthodontic Appliance | 2019 | 14 |
| Alloy, Other Noble Metal | Class 2 | Firing Paste | 2025 | 12 |
| Cement, Dental | Class 2 | Glass Ionomer Cement (Filling), Glass Ionomer Cement, Glass Ionomer Cement (Luting), UltraCore Dual Cure Resin Cement, TopCEM Dual Cure Resin Cement | 2016 | 3 |
| Crown And Bridge, Temporary, Resin | Class 2 | Pmma Block, BioTemps NOW Milling Blocks, NOBILCAM PMMA Disc | 2021 | 13 |
| Denture, Plastic, Teeth | Class 2 | Kaibiao (Maist), Kaijing, Seniors, KAIFENG (Sonning), KAITONG (Bluebell), Kaiplus and 6 more | 2010 | 26 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | PERFIT Ear Impression Silicone | 2025 | 45 |
| Material, Impression | Class 2 | Elastomeric Impression Material, A-Silicone for Bite Registration | 2014 | 6 |
| Material, Impression Tray, Resin | Class 1 | Impression Tray, Upper tray, Light Curing Tray, Lower tray, Dental Model, Wonder Light Cure Tray and 1 more | 2017 | 41 |
| Material, Tooth Shade, Resin | Class 2 | UltraCore Dual Cure Resin Cement, TopCEM Dual Cure Resin Cement | 2023 | 10 |
| Mouthguard, Prescription | Class U | Flexible Block, Milling Disc, IMPAK Disc, BioTemps NOW Milling Blocks, Pmma Block, NOBILCAM PMMA Disc | 2021 | 6 |
| Plate, Base, Shellac | Class 1 | Try-in | 2025 | 5 |
| Powder, Porcelain | Class 2 | Zirconia Block, NOBILCAM Zirconia Disc, Eternal Art Stain&Glaze Porcelain Powders, Eternal Art Porcelain Powders | 2014 | 33 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | Denture Base Polymers, Denture Base, Flexible Block, BioTemps NOW Milling Blocks, Pmma Block, NOBILCAM PMMA Disc | 2021 | 14 |
| Syringe, Restorative And Impression Material | Class 1 | Mixer & Oral tips, Dispenser, Mixer, Oral tips, Mixing tips, Dispensing gun | 2017 | 49 |
| Tray, Impression, Preformed | Class 1 | Light Curing Tray, Lower tray, Upper tray, Impression Tray | 2013 | 73 |
| Wax, Dental, Intraoral | Class 1 | Casting Wax | 2010 | 55 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Synthetic Polymer Teeth | ELM | 55 |
| Elastomeric Impression Material | ELW | 46 |
| Zirconia Block | EIH | 30 |
| Denture Base | EBI | 14 |
| Porcelain Powders | EIH | 8 |
| A-Silicone for Bite Registration | ELW | 6 |
| Try-in | EEA | 5 |
| Invisible Orthodontic Appliance | NXC | 4 |
| Flexible Block | EBI | 3 |
| Glass Ionomer Cement (Filling) | EMA | 2 |
| Dental Model | EBH | 2 |
| Surgical Guide | NDP | 2 |
| Glass Ionomer Cement (Luting) | EMA | 2 |
| Denture Base Polymers | EBI | 2 |
| Casting Wax | EGD | 2 |
Clearances
9 clearances name Shandong Huge Dental Material Corporation as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260376 | 2026-05-06 | EBI | Traditional | This company |
| K260067 | 2026-04-09 | EIH | Traditional | This company |
| K251252 | 2025-08-01 | MQC | Traditional | This company |
| K220680 | 2022-08-12 | EBI | Traditional | This company |
| K213994 | 2022-03-04 | EBI | Traditional | This company |
| K201684 | 2020-09-24 | ELW | Traditional | This company |
| K181747 | 2019-04-18 | NXC | Traditional | This company |
| K160345 | 2017-03-03 | EMA | Traditional | This company |
| K161851 | 2016-10-31 | EMA | Traditional | This company |
| K233082 | 2023-12-22 | EBF | Traditional | Rizhao Huge Biomaterials Company, Ltd. |
| K201683 | 2020-11-03 | EBG | Traditional | Huge Dental Material Co., Ltd. |
| K141421 | 2015-02-09 | EBG | Abbreviated | Rizhao Huge Dental Industry Co., Ltd. |
| K141162 | 2014-08-27 | EIH | Abbreviated | Rizhao Huge Dental Industry Co., Ltd. |
| K133071 | 2014-05-28 | ELW | Traditional | Rizhao Huge Dental Industry Co., Ltd. |
| K101029 | 2010-08-16 | ELM | Traditional | Huge Dental Material Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 1,500+ distribution partners |
| Main products | Impression silicones, Resin bonding agents, Glass ionomer cements, Composite resins, Orthodontic aligners |
| Certifications | ISO 13485, CE, FDA, MDSAP |
| Export markets | USA, EU, 60+ countries and regions |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Rizhao Sanqi Medical & Health Articles Co., Ltd. | 18 |
| Rizhao Huge Biomaterials Company, Ltd. | 7 |
| Shandong INT Medical Instruments Co., Ltd. | 4 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.