Syringe, Restorative And Impression Material
FDA product code EID · Class I (low risk) · 21 CFR 872.4565 · Dental
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941431 | Bone Graft Delivery SyringesEID · Traditional | Bio-Interfaces, Inc. | 07/12/1994SE |
| K913974 | Access Impression BarrelEID · Traditional | Centrix, Inc. | 02/25/1992SE |
| K873153 | Caulk's VPS Cartridge SystemEID · Traditional | Dentsply Intl. | 09/16/1987SE |
| K871937 | Impression SyringeEID · Traditional | Dentsply Intl. | 06/05/1987SE |
| K863998 | Coltene Jet-MixerEID · Traditional | Coltene, Inc. | 10/30/1986SE |
| K853282 | Centrix Ribbon TubesEID · Traditional | Centrix, Inc. | 08/23/1985SE |
| K851386 | Unitek Disposable Impression SyringeEID · Traditional | Unitek Corp. | 04/29/1985SE |
| K812680 | G-C Impression SyringeEID · Traditional | G-C Intl. Corp. | 10/06/1981SE |
| K812277 | Prisma-Fil CompulesEID · Traditional | Caulk Co., Div. Dentsply | 09/08/1981SE |
| K811582 | The PlacerEID · Traditional | Cavitron Corp. | 07/28/1981SE |
| K781977 | Applicator, Lee ImpressionEID · Traditional | Lee Pharmaceuticals | 12/20/1978SE |
| K770931 | Applic System Applier, EspeEID · Traditional | Espe GmbH (Us) | 06/03/1977SE |
| K770941 | Applic System Activator, EspeEID · Traditional | Espe GmbH (Us) | 06/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1034-2017 Class II | NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal…Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the… | Ultradent Products, Inc. | 12/14/2016Terminated |