Flexi-Cup Implant
FDA 510(k) K792663 · Impladent
510(k) numberK792663
Submission
- Device name
- Flexi-Cup Implant
- Applicant
- Impladent
Mchenry, IL, US - Received
- December 26, 1979
- Decision date
- January 9, 1980
- 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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| 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 |
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| 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 |
|---|---|---|
| K141764 | Tristar Bone Graft Fixation SystemJEY · Traditional | 12/18/2014SE |
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| K033098 | Osteogen SBRGLYC · Traditional | 04/27/2004SE |
| K982925 | Laminoss Dental ImplantDZE · Traditional | 05/18/1999SE |
| K933705 | Laminoss Dental ImplantDZE · Traditional | 06/24/1996SE |
| K923310 | Osteogen (Ha Resorb)LYC · Traditional | 05/31/1995SE |
| K881662 | Expanded Claimes to Osteogen(R)DZE · Traditional | 09/01/1988SN |
| K843398 | OsteogenLYC · Traditional | 12/27/1984SE |
| K812321 | Hydroxi-Flex ImplantDZE · Traditional | 10/29/1981SE |
Questions and answers
When was Flexi-Cup Implant cleared by the FDA?
Flexi-Cup Implant (K792663) received a 510(k) decision of Substantially Equivalent on January 9, 1980, 14 days after the submission was received.
What is the product code of K792663?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.