Ceramic Alloy No. DW 179
FDA 510(k) K852895 · Williams Gold Refining Co., Inc.
510(k) numberK852895
Submission
- Device name
- Ceramic Alloy No. DW 179
- Applicant
- Williams Gold Refining Co., Inc.
Buffalo, NY, US - Received
- July 9, 1985
- Decision date
- October 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from American Dent-All, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K855182 | Alloy for Metal Crown & Bridge Yellow PD #46 & #65EJS · Traditional | 03/25/1986SE |
| K860439 | DW217 #18 Crown/Bridge & DW218 #24 Ceramic AlloysEJS · Traditional | 03/20/1986SE |
| K854738 | Spartan SolderEJH · Traditional | 03/06/1986SE |
| K852093 | Alloy 7EJS · Traditional | 08/23/1985SE |
| K850699 | Spartan -Alloy for Porcelain Fused to MetalEJS · Traditional | 03/18/1985SE |
| K844395 | RenaissanceEJT · Traditional | 01/09/1985SE |
| K844394 | Renaissance Bonding AgentEJT · Traditional | 01/09/1985SE |
| K822419 | New Crown and Bridge Alloy No. DW196EJS · Traditional | 08/30/1982SE |
| K821510 | A TheniumEJS · Traditional | 06/09/1982SE |
| K811563 | Presolder for Non-Precious Dental AlloysEJS · Traditional | 07/28/1981SE |
Questions and answers
When was Ceramic Alloy No. DW 179 cleared by the FDA?
Ceramic Alloy No. DW 179 (K852895) received a 510(k) decision of Substantially Equivalent on October 21, 1985, 104 days after the submission was received.
What is the product code of K852895?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.