Espe Ketac-Bond
FDA 510(k) K844845 · Espe GmbH (Us)
510(k) numberK844845
Submission
- Device name
- Espe Ketac-Bond
- Applicant
- Espe GmbH (Us)
Lake Worth, FL, US - Received
- December 13, 1984
- Decision date
- August 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Enamelite, LLC
| 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 Espe Ketac-Bond cleared by the FDA?
Espe Ketac-Bond (K844845) received a 510(k) decision of Substantially Equivalent on August 19, 1985, 249 days after the submission was received.
What is the product code of K844845?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.