3i T3 Short Implants
FDA 510(k) K150571 · Biomet 3i
510(k) numberK150571
Submission
- Device name
- 3i T3 Short Implants
- Applicant
- Biomet 3i
Palm Beach Gardens, FL, US - Received
- March 6, 2015
- Decision date
- November 20, 2015
- 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 |
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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 |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
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More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
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| 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 |
Questions and answers
When was 3i T3 Short Implants cleared by the FDA?
3i T3 Short Implants (K150571) received a 510(k) decision of Substantially Equivalent on November 20, 2015, 259 days after the submission was received.
What is the product code of K150571?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.