Overdenture - Stud Attachment
FDA 510(k) K890713 · Austenal Dental, Inc.
510(k) numberK890713
Submission
- Device name
- Overdenture - Stud Attachment
- Applicant
- Austenal Dental, Inc.
Chicago, IL, US - Received
- February 13, 1989
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZE
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|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K862667 | Cobalt, 29.5% Chromium Alloy Dental Bake-On AlloyEJH · Traditional | 07/31/1986SE |
Questions and answers
When was Overdenture - Stud Attachment cleared by the FDA?
Overdenture - Stud Attachment (K890713) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 151 days after the submission was received.
What is the product code of K890713?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.