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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
PNP
Device class
2
Regulation
872.3630
Medical specialty
Dental
Implant
Yes

Makers by country

CountryMakers
United States12
Germany6
Switzerland3
Denmark2
Canada2
Sweden2
Israel2
China2
Spain2
Belgium1
South Korea1
France1
Liechtenstein1
Italy1
Brazil1
Costa Rica1
South Africa1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3Shape A/SCopenhagen Hovedstaden, DenmarkManufacturer2October 7, 2020000api.fda.gov
Dental Wings Inc.Montreal Quebec, CanadaManufacturer1December 26, 2024000api.fda.gov
Exocad GMBHDarmstadt Hesse, GermanyManufacturer1July 21, 2021000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandComplaint file establishment, Specification developer1December 26, 2024000api.fda.gov
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer1March 1, 2019000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer1March 1, 2019000api.fda.gov
Nobel Biocare c/o Medicim NVMechelen Antwerpen, BelgiumComplaint file establishment, Manufacturer1March 1, 2019000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1March 14, 2024000api.fda.gov
Proto3000 Inc.Vaughan Ontario, CanadaManufacturer1July 21, 2021000api.fda.gov
Rgorithm KoreaGuemcheon-gu Seoul, South KoreaManufacturer1July 18, 2023000api.fda.gov
Adin Dental Implant Systems Ltd.Afula Northern, IsraelComplaint file establishment, Manufacturer0000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer0000api.fda.gov
Biohorizons Implant Systems Inc.Birmingham, AL, United StatesManufacturer0000api.fda.gov
Creodent Hudson ValleyFishkill, NY, United StatesManufacturer0000api.fda.gov
Degudent GMBHHANAU Hesse, GermanyManufacturer0000api.fda.gov
Dentsply Implants Manufacturing GmbHHanau Hesse, GermanyContract manufacturer0000api.fda.gov
Elos Medtech Pinol A/SGoerloese Hovedstaden, DenmarkManufacturer0000api.fda.gov
Exceldent Dental Technology Development Co., Ltd.Zhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer0000api.fda.gov
Implant Protesis Dental 2004, S.L.Premia de Dalt Barcelona, SpainManufacturer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Specification developer0000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer0000api.fda.gov
Medentika GMBHHuegelsheim Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
MIS Implants Technologies Ltd.BAR LEV INDUSTRIAL PARK Northern, IsraelManufacturer0000api.fda.gov
Medentika GmbHCalw Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
New Image Dental Laboratory, Inc.Morrow, GA, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare AB, ProduktionKARLSKOGA Orebro, SwedenContract manufacturer, Manufacturer0000api.fda.gov
Nobel Biocare Procera, LLCMahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Nobel Biocare Usa, LLCYorba Linda, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
PREAT CorporationSanta Maria, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Preferred Oral Design LimitadaAlajuela, San Rafael, Costa RicaContract manufacturer0000api.fda.gov
Shimmer Computerized Dental Technology Co.,ltdZhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer, Specification developer0000api.fda.gov
Southern Implants (pty) LtdIRENE Gauteng, South AfricaExporter to the US, Manufacturer0000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Straumann Manufacturing, Inc.Andover, MA, United StatesManufacturer0000api.fda.gov
Straumann Villeret SAVILLERET Bern, SwitzerlandManufacturer0000api.fda.gov
Terrats Medical, S.L.Barbera del Valles Barcelona, SpainManufacturer0000api.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.