Prosthetic devices · 21 CFR 872 Subpart D
Dental Abutment Design Software for Dental Laboratory
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
- Companies listing it
- 3024 makers
- Brands and models
- 968
- 510(k) clearances
- 83 in five years
- FDA name
- Dental Abutment Design Software For Dental Laboratory
510(k) clearances per year, 1976–2026
Companies that list PNP
30 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | MedentiBase Titaniumbase abutment · Multi-unit TitaniumBase & Multi-unit Titanium Cap · Neodent Titanium Block for Medentika Holder · Pre-milled Abutment Blank for CARES® · +8 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A1 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A2 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3.5 · +111 | 56 | 2026 |
| Terrats Medical, S.L. | Spain | Maker | Terrats Medical S.L. | 23 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | AbutmentCAD · Clinical Screw Multi-unit Abutment N1 Trioval Conical Connection · Clinical Screw N1 Base · Clinical Screw N1 Trioval Conical Connection · +32 | 94 | 2026 |
| Elos Medtech Pinol A/S | Denmark | Maker | Elos Accurate Customized Abutment · Elos Accurate Hybrid Base · Elos Accurate Hybrid Base and Customized Abutment with Prosthetic Screws · Elos Accurate Hybrid Base Engaging · +5 | 14 | 2026 |
| Southern Implants, Inc. | South Africa | Maker | Angulated Screw Channel Solution Abutments & SI-BASE Abutments · PROVATA Implant System · Single Platform SP1 Implant System and accessories · TIB Abutment System · +1 | 22 | 2024 |
| Implant Protesis Dental 2004, S.L. | Spain | Maker | Angled Multi-unit Screw M1.4 · Angled Multi-unit Screw M1.6 · Angled Multi-unit Screw M1.8 · Angled Multi-unit Screw M2 · +751 | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | IPS e.max CAD Abutment Solutions- extra systems · Telio CAD Abutment Solutions- extra systems | 94 | 2026 |
| BioHorizons Implant Systems, Inc. | United States | Maker | CEREC Compatible Ti-Bases · Conical Ti Base Abutments | 41 | 2026 |
| Implant Direct | United States | Maker | InterActive SMARTBase Abutments · Legacy SMARTbase Abutments · SMARTbase Abutment System | 24 | 2023 |
| Young Innovations Inc | United States | Maker | Preat Abutments | 23 | 2025 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | NP CloseFit Ti Pre Milled MDTK Abutment Blank · RP CloseFit Ti Pre Milled MDTK Abutment Blank · RS CloseFit Ti Pre Milled MDTK Abutment Blank · Ti Base RS Abutment · +3 | 3 | 2026 |
| Creodent Hudson Valley | United States | Maker | Solidex | 1 | 2026 |
| Rgorithm Korea | South Korea | Maker | TRUST | 1 | 2023 |
| 3Shape A/S | Denmark | Maker | Abutment Design · Abutment designer | 7 | 2020 |
| exocad GmbH | Germany | Maker | AbutmentCAD · Ceramill Mind M-Plant · Implant Module · PlanCAD Premium AbutmentCAD | 1 | 2021 |
| Micro Precision Swiss, LLC | United States | Maker | Abutment Screw Retrieval Instrument · Implant Retrieval Instrument | — | — |
| New Image Dental Laboratory, Inc. | United States | Maker | Abutment, implant, dental, endosseous, Straumann CARES M-Series CAD/CAM System | — | — |
| Implant Logistics / AMS Micromedical | United States | Maker | Implant Logistics, Inc; Implant-One | — | — |
| Proto3000 Inc. | Canada | Maker | Exocad Exoplan | — | — |
| Preferred Oral Design Limitada | Costa Rica | Maker | Straumann CARES M-Series CAD/CAM System | — | — |
| EXCELDENT Dental Technology Development Co., Ltd. | China | Maker | Dess Implant | — | — |
| Shimmer Computerized Dental Technology Co.,LTD | China | Maker | Dess Implant | — | — |
| PaloDEx Group Oy | Finland | Foreign exporter | DTX Studio Lab | 9 | 2024 |
| National Dentex LLC | United States | Contract manufacturer | DESS Ti Base Abutments | 1 | 2012 |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | Zirconia Implant System | — | — |
| Acer Dental Lab Co Ltd | Hong Kong SAR China | Foreign exporter | Dess Implant | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 26 Dec 2024 | K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG |
| 14 Mar 2024 | K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. |
| 18 Jul 2023 | K221107 | TRUST | Rgorithm Korea |
| 21 Jul 2021 | K193352 | AbutmentCAD | exocad GmbH |
| 7 Oct 2020 | K200100 | Abutment Design | 3Shape A/S |
| 19 Aug 2020 | K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona, Inc. |
| 1 Mar 2019 | K181932 | DTX Studio design | Nobel Biocare Services AG |
| 6 Sep 2016 | K151455 | 3Shape Abutment Designer Software | 3Shape A/S |
Official records: FDA product classification for PNP · 21 CFR 872.3630.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026