Product code EID
- Device name
- Syringe, Restorative And Impression Material
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941431 | BONE GRAFT DELIVERY SYRINGES | Bio-Interfaces, Inc. | 1994-07-12 |
| K913974 | ACCESS IMPRESSION BARREL | Centrix, Inc. | 1992-02-25 |
| K873153 | CAULK'S VPS CARTRIDGE SYSTEM | Dentsply Intl. | 1987-09-16 |
| K871937 | IMPRESSION SYRINGE | Dentsply Intl. | 1987-06-05 |
| K863998 | COLTENE JET-MIXER | Coltene, Inc. | 1986-10-30 |
| K853282 | CENTRIX RIBBON TUBES | Centrix, Inc. | 1985-08-23 |
| K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Unitek Corp. | 1985-04-29 |
| K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. | 1981-10-06 |
| K812277 | PRISMA-FIL COMPULES | Caulk Co., Div. Dentsply | 1981-09-08 |
| K811582 | THE PLACER | Cavitron Corp. | 1981-07-28 |
| K781977 | APPLICATOR, LEE IMPRESSION | Lee Pharmaceuticals | 1978-12-20 |
| K770931 | APPLIC SYSTEM APPLIER, ESPE | Espe GmbH (Us) | 1977-06-03 |
| K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | Espe GmbH (Us) | 1977-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800017902203 | DX-Mixer | DXM CO., LTD | 2025-09-29 |
| 08056000372304 | Mixing Tips | ZHERMACK SPA | 2025-03-28 |
| 08056000372298 | Dynamic-static Mixing Tips | ZHERMACK SPA | 2025-03-28 |
| 08056000372311 | Mixing Tips | ZHERMACK SPA | 2025-03-28 |
| 08056000372328 | Mixing Tips | ZHERMACK SPA | 2025-03-28 |
| 08800017902029 | DX-Mixer | DXM CO., LTD | 2024-06-04 |
| 08800017902005 | DX-Mixer | DXM CO., LTD | 2024-06-04 |
| 08800017901978 | DX-Mixer | DXM CO., LTD | 2024-06-04 |
| 08800017901923 | DX-Mixer | DXM CO., LTD | 2024-06-04 |
| 08800017901893 | Dynamic Mixer | DXM CO., LTD | 2023-10-25 |
| 07615208353730 | Clinical Accessory (no MD) | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-10-25 |
| 08800017901879 | Dynamic Mixer | DXM CO., LTD | 2023-10-24 |
| 08800017901848 | DX-Mixer | DXM CO., LTD | 2023-07-31 |
| 08800017901657 | DX-Mixer | DXM CO., LTD | 2023-07-26 |
| 00020221017809 | EXEL 1mL CARRYING AND DELIVERY SYRINGE | Exel International | 2023-04-21 |
| 07615208379297 | Cannula | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-03-23 |
| 07615208339932 | Cannula | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-03-23 |
| EZHIC2020850 | Mixing Tips | ZHERMACK SPA | 2022-06-15 |
| EZHIC2020700 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC7002400 | Mixing tips 4:1 | ZHERMACK SPA | 2022-06-14 |
| EZHIC2055300 | Dynamic-static Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC2055000 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC2032330 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC2020900 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC2020860 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| EZHIC2020800 | Mixing Tips | ZHERMACK SPA | 2022-06-14 |
| 08033712562872 | PRESTIGE INTRA-ORAL TIPS 48 PCS | VANNINI DENTAL INDUSTRY SRL | 2019-09-06 |
| 08033712562865 | PRESTIGE MIXING TIPS GREEN 48 PCS | VANNINI DENTAL INDUSTRY SRL | 2019-09-06 |
| 08033712562858 | DISPENSER | VANNINI DENTAL INDUSTRY SRL | 2019-09-06 |
| 08033712562810 | PRESTIGE MIXING TIPS YELLOW 48 PCS | VANNINI DENTAL INDUSTRY SRL | 2019-09-06 |