Modified Permagum Adhesive
FDA 510(k) K881838 · Espe GmbH (Us)
510(k) numberK881838
Submission
- Device name
- Modified Permagum Adhesive
- Applicant
- Espe GmbH (Us)
Lake Worth, FL, US - Received
- May 2, 1988
- Decision date
- July 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933745 | Permagen Universal Bonding ResinEBH · Traditional | Bio-Systems Research | 01/26/1994SE |
| K930487 | Palatray LC MintEBH · Traditional | Heraeus Kulzer, Inc. | 06/18/1993SE |
| K923979 | LC Tray MaterialEBH · Traditional | Dentsply Intl. | 11/17/1992SE |
| K923549 | Paladisc LCEBH · Traditional | Heraeus Kulzer, Inc. | 09/29/1992SE |
| K912820 | Polyester Resin Hand Molded TrayEBH · Traditional | E&D Dental Products, Inc. | 08/21/1991SE |
| K905058 | Palavit LEBH · Traditional | Kulzer, Inc. | 06/06/1991SE |
| K902350 | Palatray LC Resin Impression Tray MaterialEBH · Traditional | Kulzer, Inc. | 07/26/1990SE |
| K901782 | Convertray Custom Impression Tray Material SystemEBH · Traditional | Productivity Training Corp. | 06/29/1990SE |
| K890712 | Advantage Dental Cust Dent Impress/Baseplate TraysEBH · Traditional | Advantage Dental Products, Inc. | 04/25/1989SE |
| K875257 | Impregum F AdhesiveEBH · Traditional | Espe GmbH (Us) | 03/09/1988SE |
More from Espe GmbH (Us)
| 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 Modified Permagum Adhesive cleared by the FDA?
Modified Permagum Adhesive (K881838) received a 510(k) decision of Substantially Equivalent on July 27, 1988, 86 days after the submission was received.
What is the product code of K881838?
The FDA product code is EBH – Material, Impression Tray, Resin, a Class I (low risk) device regulated under 21 CFR 872.3670.