Immediate Molar Implants
FDA 510(k) K241753 · Biomet 3i, LLC
510(k) numberK241753
Submission
- Device name
- Immediate Molar Implants
- Applicant
- Biomet 3i, LLC
Palm Beach Gardens, FL, US - Received
- June 18, 2024
- Decision date
- October 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
|---|---|---|
| K251660 | T3 Pro Implants ZimVie Packaging SystemDZE · Special | 06/27/2025SE |
| K241032 | BellaTek BarsNHA · Traditional | 07/15/2024SE |
| K220978 | TSX ImplantsDZE · Traditional | 09/14/2022SE |
| K213672 | T3 Pro ImplantsDZE · Traditional | 03/28/2022SE |
| K212730 | BellaTek Encode Emergence Healing AbutmentsNHA · Special | 12/21/2021SE |
| K192522 | TSV BellaTek Express and BellaTek Flex AbutmentsNHA · Traditional | 12/09/2019SE |
| K183138 | Certain BellaTek Express and BellaTek Flex AbutmentsNHA · Traditional | 07/02/2019SE |
| K173374 | TSV BellaTek Encode Healing AbutmentsNHA · Traditional | 12/13/2017SE |
| K170013 | Eztetic BellaTek Encode Healing AbutmentsNHA · Traditional | 09/21/2017SE |
| K150571 | 3i T3 Short ImplantsDZE · Traditional | 11/20/2015SE |
Questions and answers
When was Immediate Molar Implants cleared by the FDA?
Immediate Molar Implants (K241753) received a 510(k) decision of Substantially Equivalent on October 23, 2024, 127 days after the submission was received.
What is the product code of K241753?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.