Chrysalis Intelligence · Sponsors · Rizhao Huge Biomaterials Company, Ltd.

Rizhao Huge Biomaterials Company, Ltd.

Rizhao City, CN · 13 510(k) clearances

Total clearances
13
2020-09-25 → 2025-12-12
Last 12 months
1
Product codes
5
Most recent
2025-12-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EBF Material, Tooth Shade, Resin Class II Dental 4 2024-12-20
KLE Agent, Tooth Bonding, Resin Class II Dental 4 2024-12-20
EMA Cement, Dental Class II Dental 3 2025-12-12
EBG Crown And Bridge, Temporary, Resin Class II Dental 1 2025-06-23
EBC Sealant, Pit And Fissure, And Conditioner Class II Dental 1 2023-07-25
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2025-12-12 K252785 TopCEM Vigor SA Self-Adhesive Resin Cement EMA Class II Dental
2025-06-23 K251271 TempFIT Temporary Crown and Bridge Resin EBG Class II Dental
2024-12-20 K242572 TopCEM-Try in Veneer Try-in Gel EBF Class II Dental
2024-12-20 K242530 HF-Etchant Hydrofluoric Acid Etching Gel KLE Class II Dental
2024-11-08 K242749 TopCEM Ceramic Primer Ceramic Coupling Agent KLE Class II Dental
2024-06-28 K241204 TopCEM-Veneer Light Cure Veneer Cement EMA Class II Dental
2023-12-22 K233082 TopCEM Dual Cure Resin Cement EBF Class II Dental
2023-07-25 K230455 Enamel Coating Resin EBC Class II Dental
2022-10-12 K221510 TrusFIL-Flow Flowable Composite Restorative EBF Class II Dental
2022-09-12 K221450 Phosphoric Acid Etching Gel KLE Class II Dental
2021-10-06 K202063 TrusFIL Universal Composite Restorative EBF Class II Dental
2020-09-29 K201790 Dual Cure Resin Cement EMA Class II Dental
2020-09-25 K201787 Light Cure Dental Adhesive KLE Class II Dental