Austenal Dental Composite Resin
FDA 510(k) K854957 · Austenal Dental, Inc.
510(k) numberK854957
Submission
- Device name
- Austenal Dental Composite Resin
- Applicant
- Austenal Dental, Inc.
Chicago, IL, US - Received
- December 11, 1985
- Decision date
- January 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Enamelite, LLC
| 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 Austenal Dental Composite Resin cleared by the FDA?
Austenal Dental Composite Resin (K854957) received a 510(k) decision of Substantially Equivalent on January 30, 1986, 50 days after the submission was received.
What is the product code of K854957?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.