Applic System Applier, Espe
FDA 510(k) K770931 · Espe GmbH (Us)
510(k) numberK770931
Submission
- Device name
- Applic System Applier, Espe
- Applicant
- Espe GmbH (Us)
Mchenry, IL, US - Received
- May 23, 1977
- Decision date
- June 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EID
| 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 |
More from Cavitron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K925027 | Photac-Fil AplicapEMA · Traditional | 06/18/1993SE |
| K915005 | Photac-Bond Aplicap, ModificationEMA · Traditional | 01/14/1992SE |
| K913966 | Sono(R) -CemEBF · Traditional | 01/14/1992SE |
| K913857 | Rocatec(R) -PlusEJH · Traditional | 12/16/1991SE |
| K913965 | Espe(R) -SilKLE · Traditional | 12/04/1991SE |
| K905604 | Visio-Gem Art-SystemEBF · Traditional | 03/29/1991SE |
| K904096 | Photac-BondEJK · Traditional | 11/19/1990SE |
| K904097 | Photac-Bond AplicapEJK · Traditional | 11/09/1990SE |
| K904289 | Pertac Universal BondKLE · Traditional | 11/01/1990SE |
| K900510 | Pertac-HybridEBF · Traditional | 08/09/1990SE |
Questions and answers
When was Applic System Applier, Espe cleared by the FDA?
Applic System Applier, Espe (K770931) received a 510(k) decision of Substantially Equivalent on June 3, 1977, 11 days after the submission was received.
What is the product code of K770931?
The FDA product code is EID – Syringe, Restorative And Impression Material, a Class I (low risk) device regulated under 21 CFR 872.4565.