Albabond 60
FDA 510(k) K883758 · Degussa Dental, Inc.
510(k) numberK883758
Submission
- Device name
- Albabond 60
- Applicant
- Degussa Dental, Inc.
Long Island, NY, US - Received
- September 6, 1988
- Decision date
- October 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 510(k) | Device | Decision |
|---|---|---|
| K883511 | Albabond EEJS · Traditional | 10/06/1988SE |
| K883509 | Heraeus DG 63EJS · Traditional | 09/22/1988SE |
| K883508 | Hera HEJT · Traditional | 09/22/1988SE |
| K883510 | Degupal 4EJS · Traditional | 09/15/1988SE |
| K883507 | Heraeus C SpecialEJS · Traditional | 09/15/1988SE |
| K883512 | Heraeus WhiteEJS · Traditional | 09/06/1988SE |
| K883036 | Palliag NF IIIEJT · Traditional | 08/12/1988SE |
| K880033 | DegustarEJT · Traditional | 03/07/1988SE |
| K871808 | Duceram-Metal-Ceramic Dental Porcelain SystemELL · Traditional | 06/05/1987SE |
| K870230 | Alloy for Dental Amalgam Luxalloy Non Gamma 2EJJ · Traditional | 05/20/1987SE |
Questions and answers
When was Albabond 60 cleared by the FDA?
Albabond 60 (K883758) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 36 days after the submission was received.
What is the product code of K883758?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.