EMA — Cement, Dental Class II
FDA Device Classification
Classification Details
- Product Code
- EMA
- Device Class
- Class II
- Regulation Number
- 872.3275
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K254063 | kulzer | iCEM Universal Plus | December 19, 2025 |
| K252785 | rizhao huge biomaterials company | TopCEM Vigor SA Self-Adhesive Resin Cement | December 12, 2025 |
| K252808 | shofu dental corporation | GlasIonomer FX-LC | December 9, 2025 |
| K252165 | shofu dental corporation | ZIRCONOMER P | October 28, 2025 |
| K250953 | gc america | EQUIA LC ONE | September 19, 2025 |
| K251775 | belport company, inc., gingi-pak | RODIN Cement | September 2, 2025 |
| K251470 | shofu dental corporation | ResiCem EX | July 11, 2025 |
| K250156 | bisco | Choice 2 DC | July 11, 2025 |
| K250566 | spident co | EsCem RMGI | June 20, 2025 |
| K242366 | overfibers | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut | January 10, 2025 |
| K240714 | cosmedent | Insure® Universal; Insure® Universal Automix | July 24, 2024 |
| K241204 | rizhao huge biomaterials company | TopCEM-Veneer Light Cure Veneer Cement | June 28, 2024 |
| K240888 | dentsply sirona | Calibra Abutment Resin Cement | April 2, 2024 |
| K233161 | shofu dental corporation | BeautiLink SA | September 28, 2023 |
| K231552 | diadent group international | Dia-Cem | July 28, 2023 |
| K214076 | spident co | EsCem | December 19, 2022 |
| K222253 | shofu dental corporation | GlasIonomer FX ULTRA | September 22, 2022 |
| K214118 | sdi limited | Riva Cem Automix | August 30, 2022 |
| K220640 | voco | Bifix Hybrid Abutment Cement | August 23, 2022 |
| K213609 | imicryl dis malzemeleri sanayi ve ticaret | NOVA RESIN dual cure, self adhesive resin cement | August 9, 2022 |