Product code EMA
- Device name
- Cement, Dental
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3275
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | 2026-05-18 |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | 2026-03-20 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 2025-12-09 |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 2025-10-28 |
| K250953 | EQUIA LC ONE | GC America, Inc. | 2025-09-19 |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | 2025-01-10 |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 |
| K233161 | BeautiLink SA | Shofu Dental Corporation | 2023-09-28 |
| K231552 | Dia-Cem | DiaDent Group International | 2023-07-28 |
| K214076 | EsCem | Spident Co., Ltd. | 2022-12-19 |
| K222253 | GlasIonomer FX ULTRA | Shofu Dental Corporation | 2022-09-22 |
| K214118 | Riva Cem Automix | Sdi Limited | 2022-08-30 |
| K220640 | Bifix Hybrid Abutment Cement | Voco GmbH | 2022-08-23 |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 |
| K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2022-06-01 |
| K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | 2022-01-20 |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-11-02 |
| K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021-07-13 |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021-06-11 |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | 2021-05-13 |
| K200798 | G-CEM ONE | GC America, Inc. | 2020-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07615208293470 | SpeedCEM / SpeedCEM Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-10-14 |
| 07615208293487 | SpeedCEM / SpeedCEM Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-10-14 |
| 07615208294965 | SpeedCEM / SpeedCEM Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-10-14 |
| 07615208292855 | Speedcem 100 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-10-14 |
| 07615208298659 | Multilink Automix / Primer A+B | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-10-25 |
| 07615208298666 | Multilink Automix / Primer A+B | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208300833 | Multilink Automix / Primer A+B | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208315301 | Telio Desensitizer | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-09-29 |
| 07899633828456 | Suppra Core | Dentscare Ltda | 2021-11-01 |
| 07899633828449 | Suppra Core | Dentscare Ltda | 2021-11-01 |
| 07899633828425 | Suppra Core | Dentscare Ltda | 2021-11-01 |
| 07899633815197 | Allcem Core | Dentscare Ltda | 2019-12-02 |
| 07899633815210 | Allcem Core | Dentscare Ltda | 2019-12-02 |
| 07899633815203 | Allcem Core | Dentscare Ltda | 2019-12-02 |
| 07899633815180 | Allcem Core | Dentscare Ltda | 2019-12-02 |
| 08806387894049 | Metacem Set | Meta Biomed Co., Ltd. | 2018-08-30 |
| 08806387894094 | Metacem TL | Meta Biomed Co., Ltd. | 2018-08-30 |
| 08806387894087 | Metacem OP | Meta Biomed Co., Ltd. | 2018-08-30 |
| 08806387894070 | Metacem B2 | Meta Biomed Co., Ltd. | 2018-08-30 |
| 08806387894063 | Metacem A3 | Meta Biomed Co., Ltd. | 2018-08-30 |
| 08806387894056 | Metacem A1 | Meta Biomed Co., Ltd. | 2018-08-30 |
| H44457412140 | Vitrebond™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011003130 | Durelon™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011003620 | Durelon™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004040 | Ketac™ Cem Maxicap™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004200 | Ketac™ Cem Aplicap™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004380 | Ketac™ Cem radiopaque | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004460 | Ketac™ Cem radiopaque | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004530 | Ketac™ Cem radiopaque | 3M Deutschland GmbH | 2016-09-24 |
| J001702011004610 | Ketac™ Cem radiopaque | 3M Deutschland GmbH | 2016-09-24 |