F-Series Implant
FDA 510(k) K850706 · Omni Intl., Inc.
510(k) numberK850706
Submission
- Device name
- F-Series Implant
- Applicant
- Omni Intl., Inc.
Tampa, FL, US - Received
- February 22, 1985
- Decision date
- April 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K984066 | Omnigrip, Latex Surgical Glove, Powder-Free with Protein Labeling ClaimKGO · Traditional | 01/13/1999SE |
| K984064 | Omnigrip, Latex Surgical Glove, Powder FreeKGO · Traditional | 01/08/1999SE |
| K853255 | Omnimed I.V. Solution Admin. SetFPA · Traditional | 08/23/1985SE |
| K851938 | Omnimed Surgical GownFYA · Traditional | 06/28/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | 05/31/1985SE |
| K851734 | Omnimed Superior Transducer ProtectorFIB · Traditional | 05/23/1985SE |
| K850112 | Omnimed IV Solution Administration SetFPA · Traditional | 02/22/1985SE |
| K850066 | Omnimed Nasal Oxygen CannulaCAT · Traditional | 01/24/1985SE |
| K831147 | Omniprobe Electrical Nerve StimulatorGZJ · Traditional | 07/18/1983SE |
| K821523 | Omni TENSGZJ · Traditional | 06/16/1982SE |
Questions and answers
When was F-Series Implant cleared by the FDA?
F-Series Implant (K850706) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 47 days after the submission was received.
What is the product code of K850706?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.