EMA — Cement, Dental Class II
FDA product code EMA covers "Cement, Dental", a Class II medical device regulated under 21 CFR 872.3275. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261166 | diadent group international | DIA-CEM | July 9, 2026 |
| K254109 | gc america | G-CEM UNIVERSAL | May 18, 2026 |
| K253337 | inter-med | REGEN Bioactive Cement | April 15, 2026 |
| K252606 | voco | Bifix Veneer LC, Bifix Veneer Try-In | March 20, 2026 |
| 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 |
| K250156 | bisco | Choice 2 DC | July 11, 2025 |
| K251470 | shofu dental corporation | ResiCem EX | 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 |