Cobalt, 29.5% Chromium Alloy Dental Bake-On Alloy
FDA 510(k) K862667 · Austenal Dental, Inc.
510(k) numberK862667
Submission
- Device name
- Cobalt, 29.5% Chromium Alloy Dental Bake-On Alloy
- Applicant
- Austenal Dental, Inc.
Chicago, IL, US - Received
- July 14, 1986
- Decision date
- July 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Decision |
|---|---|---|
| K890713 | Overdenture - Stud AttachmentDZE · Traditional | 07/14/1989SE |
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| 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 |
| K864826 | A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy)EJH · Traditional | 02/10/1987SE |
| K862856 | Palladium Based Dent Alloys/Porcelain Metal RestorEJS · Traditional | 08/26/1986SE |
Questions and answers
When was Cobalt, 29.5% Chromium Alloy Dental Bake-On Alloy cleared by the FDA?
Cobalt, 29.5% Chromium Alloy Dental Bake-On Alloy (K862667) received a 510(k) decision of Substantially Equivalent on July 31, 1986, 17 days after the submission was received.
What is the product code of K862667?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.