NHA — Abutment, Implant, Dental, Endosseous Class II
FDA product code NHA covers "Abutment, Implant, Dental, Endosseous", a Class II medical device regulated under 21 CFR 872.3630. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHA
- Device Class
- Class II
- Regulation Number
- 872.3630
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261147 | jjgc indústria e comércio de materiais dentários | Neodent Implant System - NeoConvert Fit | July 1, 2026 |
| K261122 | imagine milling technologies | MIST IC | June 27, 2026 |
| K260061 | biohorizons implant systems | BioHorizons CEREC Compatible Ti-Bases | June 26, 2026 |
| K253922 | jjgc indústria e comércio de materiais dentários | Neodent Scannable Healing Abutment | June 15, 2026 |
| K254145 | smart denture conversions | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | June 11, 2026 |
| K260564 | terrats medical sl | DESS Dental Smart Solutions | June 9, 2026 |
| K252904 | sic invent | SIC Abutments including CAD/CAM Solutions | June 3, 2026 |
| K253774 | elos medtech pinol | Elos Accurate® Denture Fixation System | May 20, 2026 |
| K253372 | hiossen | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | May 14, 2026 |
| K260460 | institut straumann | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | May 7, 2026 |
| K253804 | terrats medical sl | DESS Dental Smart Solutions | April 16, 2026 |
| K260555 | zest anchors | LOCATOR® Angled Abutment | April 9, 2026 |
| K251434 | osstem implant co | Healing Abutment System | March 4, 2026 |
| K251515 | creodent hudson valley | Solidex® Ti-Links and Screws | February 10, 2026 |
| K243732 | talladium españa, sl | Multi-Unit DAS System | January 29, 2026 |
| K251427 | hiossen | EK MULTI ANGLED 30 ABUTMENT | January 29, 2026 |
| K253315 | institut straumann | Straumann Variobase Abutments XC for Bridge/Bar | January 22, 2026 |
| K253253 | implant protesis dental 2004, s.l | IPDmilled Blanks | January 22, 2026 |
| K252727 | jjgc indústria e comércio de materiais dentários | Neodent InLab Validated Workflow | January 7, 2026 |
| K253312 | orangecad med | OrangeCAD Med Abutments | December 23, 2025 |