Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3630](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3630) → NHA — Abutment, Implant, Dental, Endosseous # NHA · Abutment, Implant, Dental, Endosseous _Dental · 21 CFR 872.3630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA ## Overview - **Product Code:** NHA - **Device Name:** Abutment, Implant, Dental, Endosseous - **Regulation:** [21 CFR 872.3630](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3630) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **Implant:** yes ## Identification An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. ## Classification Rationale Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.) ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.) ## Recent Cleared Devices (20 of 702) Showing 20 most recent of 702 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253804](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K253804.md) | DESS Dental Smart Solutions | Terrats Medical SL | Apr 16, 2026 | SESE | | [K260555](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K260555.md) | LOCATOR® Angled Abutment | Zest Anchors, LLC | Apr 9, 2026 | SESE | | [K251434](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K251434.md) | Healing Abutment System | Osstem Implant Co., Ltd. | Mar 4, 2026 | SESE | | [K251515](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K251515.md) | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | Feb 10, 2026 | SESE | | [K251427](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K251427.md) | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | Jan 29, 2026 | SESE | | [K243732](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K243732.md) | Multi-Unit DAS System | Talladium España, SL | Jan 29, 2026 | SESE | | [K253315](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K253315.md) | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | Jan 22, 2026 | SESE | | [K253253](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K253253.md) | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | Jan 22, 2026 | SESE | | [K252727](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252727.md) | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | Jan 7, 2026 | SESE | | [K253341](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K253341.md) | Custom Abutments AS | Medentika GmbH | Dec 23, 2025 | SESE | | [K253312](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K253312.md) | OrangeCAD Med Abutments | Orangecad Med GmbH | Dec 23, 2025 | SESE | | [K252320](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252320.md) | SIMDA Abutments | Simda Co., Ltd. | Dec 18, 2025 | SESE | | [K252343](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252343.md) | Atlantis® Abutments in Titanium | Dentsply Sirona | Dec 9, 2025 | SESE | | [K252248](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252248.md) | CEREC Tessera Abutment System | Dentsply Sirona | Nov 26, 2025 | SESE | | [K251205](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K251205.md) | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | Nov 21, 2025 | SESE | | [K252582](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252582.md) | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | Nov 18, 2025 | SESE | | [K251547](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K251547.md) | DESS Dental Smart Solutions | Terrats Medical SL | Oct 31, 2025 | SESE | | [K252384](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252384.md) | DESS® Dental Smart Solutions | Terrats Medical SL | Oct 23, 2025 | SESE | | [K252266](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K252266.md) | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Oct 17, 2025 | SESE | | [K250178](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K250178.md) | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | Oct 17, 2025 | SESE | ## Top Applicants - Institut Straumann AG — 45 clearances - Nobel Biocare AB — 41 clearances - Zimmer Dental, Inc. — 21 clearances - Dentsply Sirona — 20 clearances - Terrats Medical SL — 20 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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