Restore TPS Dental Implant System Sustain TPS Dental Implant System
FDA 510(k) K954819 · Lifecore Biomedical, Inc.
510(k) numberK954819
Submission
- Device name
- Restore TPS Dental Implant System Sustain TPS Dental Implant System
- Applicant
- Lifecore Biomedical, Inc.
Chaska, MN, US - Received
- October 20, 1995
- Decision date
- January 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
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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 |
| 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 |
|---|---|---|
| K073032 | Primaconnex SD Esthetic Contour Zi AbutmentsNHA · Special | 11/16/2007SE |
| K072241 | Primaconnex Cad/Cam Abutment SystemNHA · Abbreviated | 11/09/2007SE |
| K072768 | Restore, STAGE-1, Renova Primasolo and Primaconnex Dental ImplantsDZE · Special | 10/23/2007SE |
| K072572 | Primaconnex RD and WD Esthetic Contour Zi AbutmentsNHA · Special | 10/05/2007SE |
| K062876 | Primaconnex Ceramic AbutmentsNHA · Traditional | 11/01/2006SE |
| K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…ELL · Traditional | 05/22/2006SE |
| K053643 | Stage- 1 Temporary/Healing Cap, Model 42021-42026NHA · Special | 01/23/2006SE |
| K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…DZE · Abbreviated | 09/09/2005SE |
| K050506 | Primasolo One-Piece Implants & Healing CapsDZE · Abbreviated | 04/15/2005SE |
| K041324 | Calmatrix Calcium Sulfate Bone Graft BinderLYC · Traditional | 07/19/2004SE |
Questions and answers
When was Restore TPS Dental Implant System Sustain TPS Dental Implant System cleared by the FDA?
Restore TPS Dental Implant System Sustain TPS Dental Implant System (K954819) received a 510(k) decision of Substantially Equivalent on January 11, 1996, 83 days after the submission was received.
What is the product code of K954819?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.