Data / Medical devices / Dental Abutment Design Software For Dental Laboratory
Dental Abutment Design Software For Dental Laboratory (PNP): 41 FDA-registered makers in 17 countries
41 establishments in 17 countries are registered with the FDA to make Dental Abutment Design Software For Dental Laboratory (product code PNP, Class 2, 21 CFR 872.3630). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 26, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PNP
- Device class
- 2
- Regulation
- 872.3630
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Germany | 6 |
| Switzerland | 3 |
| Denmark | 2 |
| Canada | 2 |
| Sweden | 2 |
| Israel | 2 |
| China | 2 |
| Spain | 2 |
| Belgium | 1 |
| South Korea | 1 |
| France | 1 |
| Liechtenstein | 1 |
| Italy | 1 |
| Brazil | 1 |
| Costa Rica | 1 |
| South Africa | 1 |
Makers of Dental Abutment Design Software For Dental Laboratory
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3Shape A/S | Copenhagen Hovedstaden, Denmark | Manufacturer | 2 | October 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dental Wings Inc. | Montreal Quebec, Canada | Manufacturer | 1 | December 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Exocad GMBH | Darmstadt Hesse, Germany | Manufacturer | 1 | July 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Complaint file establishment, Specification developer | 1 | December 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare AB | GOTEBORG Vastra Gotaland, Sweden | Specification developer | 1 | March 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare Services AG | Kloten Zurich, Switzerland | Specification developer | 1 | March 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare c/o Medicim NV | Mechelen Antwerpen, Belgium | Complaint file establishment, Manufacturer | 1 | March 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | March 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Proto3000 Inc. | Vaughan Ontario, Canada | Manufacturer | 1 | July 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Rgorithm Korea | Guemcheon-gu Seoul, South Korea | Manufacturer | 1 | July 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Adin Dental Implant Systems Ltd. | Afula Northern, Israel | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biohorizons Implant Systems Inc. | Birmingham, AL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creodent Hudson Valley | Fishkill, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degudent GMBH | HANAU Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Implants Manufacturing GmbH | Hanau Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Pinol A/S | Goerloese Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implant Direct Sybron Manufacturing LLC | Thousand Oaks, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implant Protesis Dental 2004, S.L. | Premia de Dalt Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implant Logistics / AMS Micromedical | Sparta, WI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JJGC Industria e Comercio de Materiais Dentarios SA | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medentika GMBH | Huegelsheim Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MIS Implants Technologies Ltd. | BAR LEV INDUSTRIAL PARK Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medentika GmbH | Calw Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Image Dental Laboratory, Inc. | Morrow, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare AB, Produktion | KARLSKOGA Orebro, Sweden | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Procera, LLC | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Usa, LLC | Yorba Linda, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PREAT Corporation | Santa Maria, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preferred Oral Design Limitada | Alajuela, San Rafael, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shimmer Computerized Dental Technology Co.,ltd | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southern Implants (pty) Ltd | IRENE Gauteng, South Africa | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Villeret SA | VILLERET Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terrats Medical, S.L. | Barbera del Valles Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.