Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
Shandong Huge Dental Material Corporation appears in FDA device records in Rizhao Shandong, CN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Shandong Huge Dental Material Corporation between 2016 and 2026. The busiest year on record is 2022, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260376 | Denture Base | EBI | Substantially Equivalent | |
| K260067 | Eternal Art Porcelain Powders | EIH | Substantially Equivalent | |
| K251252 | NOBILCAM IMPAK Disc | MQC | Substantially Equivalent | |
| K220680 | Denture Base Polymers | EBI | Substantially Equivalent | |
| K213994 | Flexible Block | EBI | Substantially Equivalent | |
| K201684 | A-Silicone for Bite Registration | ELW | Substantially Equivalent | |
| K181747 | Orthodontic Appliance | NXC | Substantially Equivalent | |
| K160345 | Glass Ionomer Cement | EMA | Substantially Equivalent | |
| K161851 | Glass Ionomer Cement (Luting) | EMA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008320092 | 3008320092 | Shandong Huge Dental Material Corporation | No. 68 Shanhai Road, Donggang District, Rizhao Shandong 276800 CN | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- NXCAligner, Sequential
- EJSAlloy, Other Noble Metal
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- ELMDenture, Plastic, Teeth
- ESDHearing Aid, Air-Conduction, Prescription
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EEAPlate, Base, Shellac
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- EIDSyringe, Restorative And Impression Material
- EHYTray, Impression, Preformed
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain