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 |
|---|---|---|---|
| 00197998226731 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226748 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226755 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226762 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226779 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226786 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226809 | Solventum™ Paradigm™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226816 | Solventum™ Paradigm™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226823 | Solventum™ Paradigm™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226847 | Solventum™ Garant™ | Solventum Germany GmbH | 2026-10-08 |
| 00197998226724 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 00810111542951 | Accessory | BISCO INC. | 2026-10-01 |
| 00883205041005 | Thermo Clone | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 08800017902562 | EZ VPS Impression Transfer Connectors | DXM CO., LTD | 2026-08-21 |
| 08800017902524 | EZ VPS Impression Transfer Connectors | DXM CO., LTD | 2026-08-21 |
| 07615208353723 | Mixing Tips | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-08-19 |
| 00840456200940 | JMU | JMU DENTAL, INC | 2026-07-20 |
| 00840456216743 | JMU | JMU DENTAL, INC | 2026-07-20 |
| 00840456218198 | JMU | JMU DENTAL, INC | 2026-07-20 |
| 00840456218204 | JMU | JMU DENTAL, INC | 2026-07-20 |
| 07615208474398 | Clinical Auxiliary (no MD) | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-07-14 |
| 08809518346721 | Disposable Tip | MEDICLUS CO.,LTD | 2026-06-05 |
| 00020221017809 | EXEL 1mL CARRYING AND DELIVERY SYRINGE | Exel International | 2023-04-21 |
| 08800040686200 | Osstem Mixing Tip | Osstem Implant Co.,Ltd. | 2022-12-08 |
| 08800040686217 | Osstem Mixing Tip | Osstem Implant Co.,Ltd. | 2022-12-08 |
| 08800040686224 | Osstem Mixing Tip | Osstem Implant Co.,Ltd. | 2022-12-08 |
| 08800040686231 | Osstem Mixing Tip | Osstem Implant Co.,Ltd. | 2022-12-08 |
| 08800121767071 | Osstem Mixing Tip | Osstem Implant Co.,Ltd. | 2022-12-08 |
| 00842092155844 | Implantlink | Preat Corporation | 2022-10-25 |
| 00190746035050 | Impressa/Sure | AMERICAN ORTHODONTICS CORPORATION | 2022-04-07 |