A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy)
FDA 510(k) K864826 · Austenal Dental, Inc.
510(k) numberK864826
Submission
- Device name
- A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy)
- Applicant
- Austenal Dental, Inc.
Chicago, IL, US - Received
- December 9, 1986
- Decision date
- February 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123929 | Begopal+EJH · Abbreviated | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 03/14/2013SE |
| K040180 | Continum VEJH · Traditional | Aalba Dent, Inc. | 03/04/2004SE |
| K040179 | ContinumEJH · Traditional | Aalba Dent, Inc. | 03/03/2004SE |
| K033356 | Verasoft EsEJH · Traditional | Aalba Dent, Inc. | 12/30/2003SE |
| K033045 | Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional | American Green Dent. Mfg, Inc. | 12/23/2003SE |
| K032136 | Wirobond CEJH · Traditional | Bego U.S.A. | 09/04/2003SE |
| K031627 | Nano-TicrownEJH · Traditional | Nano-Write Corp. | 06/11/2003SE |
| K030632 | PD Casta-HEJH · Traditional | Mountain Medico, Inc. | 05/07/2003SE |
| K030416 | Ceracast-VEJH · Traditional | Mountain Medico, Inc. | 04/14/2003SE |
| K030161 | SuperbondEJH · Traditional | American Dent-All, Inc. | 03/17/2003SE |
More from American Dent-All, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890713 | Overdenture - Stud AttachmentDZE · Traditional | 07/14/1989SE |
| K883799 | Base, Denture, Relining, Repairing, Rebasing,ResinEBI · Traditional | 10/20/1988SE |
| K880875 | Vitallium Equipoise AlloyEJH · Traditional | 04/07/1988SE |
| K871849 | Light Cure Denture GlazeEBI · Traditional | 08/10/1987SE |
| K872746 | Vitallium WireEJW · Traditional | 07/21/1987SE |
| K863630 | Austenal Acupac 20 Denture Base MaterialEBI · Traditional | 03/11/1987SE |
| K865025 | Austenal Condensing InstrumentEKG · Traditional | 02/19/1987SE |
| K862557 | Austenal Acusoft Soft LinerEBI · Traditional | 02/19/1987SE |
| K862856 | Palladium Based Dent Alloys/Porcelain Metal RestorEJS · Traditional | 08/26/1986SE |
| K862667 | Cobalt, 29.5% Chromium Alloy Dental Bake-On AlloyEJH · Traditional | 07/31/1986SE |
Questions and answers
When was A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy) cleared by the FDA?
A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy) (K864826) received a 510(k) decision of Substantially Equivalent on February 10, 1987, 63 days after the submission was received.
What is the product code of K864826?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.