BellaTek Bars
FDA 510(k) K241032 · Biomet 3i, LLC
510(k) numberK241032
Submission
- Device name
- BellaTek Bars
- Applicant
- Biomet 3i, LLC
Palm Beach Gardens, FL, US - Received
- April 16, 2024
- Decision date
- July 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional | Nobel Biocare AB | 08/06/2026SE |
| K261147 | Neodent Implant System - NeoConvert FitNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 07/01/2026SE |
| K261122 | Mist IcNHA · Traditional | Imagine Milling Technologies, LLC | 06/27/2026SE |
| K260061 | BioHorizons CEREC Compatible Ti-BasesNHA · Traditional | BioHorizons Implant Systems, Inc. | 06/26/2026SE |
| K253922 | Neodent Scannable Healing AbutmentNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 06/15/2026SE |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)NHA · Abbreviated | Smart Denture Conversions, LLC | 06/11/2026SE |
| K260564 | DESS Dental Smart SolutionsNHA · Traditional | Terrats Medical SL | 06/09/2026SE |
| K252904 | SIC Abutments including CAD/CAM SolutionsNHA · Traditional | Sic Invent AG | 06/03/2026SE |
| K253774 | Elos Accurate® Denture Fixation SystemNHA · Traditional | Elos Medtech Pinol A/S | 05/20/2026SE |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | Hiossen, Inc. | 05/14/2026SE |
More from Hiossen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251660 | T3 Pro Implants ZimVie Packaging SystemDZE · Special | 06/27/2025SE |
| K241753 | Immediate Molar ImplantsDZE · Traditional | 10/23/2024SE |
| 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 BellaTek Bars cleared by the FDA?
BellaTek Bars (K241032) received a 510(k) decision of Substantially Equivalent on July 15, 2024, 90 days after the submission was received.
What is the product code of K241032?
The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.