GDC 1453 Casting Alloy
FDA 510(k) K854285 · Deringer-Ney, Inc.
510(k) numberK854285
Submission
- Device name
- GDC 1453 Casting Alloy
- Applicant
- Deringer-Ney, Inc.
Bloomfield, CT, US - Received
- October 25, 1985
- Decision date
- December 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| 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 |
|---|---|---|
| K933178 | GDC 3509EJT · Traditional | 10/14/1993SE |
| K930482 | Dental Casting Alloy, Modification - PF-3EJT · Traditional | 03/31/1993SE |
| K930481 | Dental Casting Alloy MODIFICATION-PF-4EJT · Traditional | 03/31/1993SE |
| K925273 | GDC 3445EJS · Traditional | 12/21/1992SE |
| K920922 | GDC 3367EJS · Traditional | 05/05/1992SE |
| K920060 | Dental Solder AlloyEJT · Traditional | 04/02/1992SE |
| K920887 | GDC-3338, Dental Solder AlloyEJS · Traditional | 03/19/1992SE |
| K910065 | GDC-3200 Dental SolderEJT · Traditional | 03/15/1991SE |
| K904695 | GDC-1501EJT · Traditional | 01/02/1991SE |
| K904614 | GDC-1475EJT · Traditional | 12/19/1990SE |
Questions and answers
When was GDC 1453 Casting Alloy cleared by the FDA?
GDC 1453 Casting Alloy (K854285) received a 510(k) decision of Substantially Equivalent on December 27, 1985, 63 days after the submission was received.
What is the product code of K854285?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.