Overdenture Attachment
FDA 510(k) K891613 · Implant Innovations International, Inc.
510(k) numberK891613
Submission
- Device name
- Overdenture Attachment
- Applicant
- Implant Innovations International, Inc.
West Palm Beach, FL, US - Received
- March 20, 1989
- Decision date
- October 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
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| 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 |
|---|---|---|
| K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationDZE · Traditional | 03/13/1995SE |
| K932123 | Implant Innovation Pre-Angled Abutment SystemDZE · Traditional | 05/27/1994SE |
| K911655 | ImplaretteEKJ · Traditional | 10/21/1991SE |
| K905303 | Abutment GloEJR · Traditional | 06/10/1991SE |
| K911701 | G-Floss & G-Floss IIJES · Traditional | 05/15/1991SE |
| K891612 | Drilling Machine W/Handpieces & Internal Irriga.EFD · Traditional | 06/12/1989SE |
| K891617 | Insertion ToolsDZE · Traditional | 05/01/1989SE |
| K891618 | Titanium ForcepsDZE · Traditional | 04/17/1989SE |
| K891615 | Surgical DrillsDZE · Traditional | 04/17/1989SE |
| K874590 | Innovative Implants and Cover ScrewsDZE · Traditional | 05/11/1988SE |
Questions and answers
When was Overdenture Attachment cleared by the FDA?
Overdenture Attachment (K891613) received a 510(k) decision of Substantially Equivalent on October 10, 1989, 204 days after the submission was received.
What is the product code of K891613?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.