Dental Abutment Design Software For Dental Laboratory
Dental · 21 CFR 872.3630
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.
Recent MDR events
4 adverse event reports on file
- BioHorizons Conical Ti BaseJul 31, 2026MalfunctionBiohorizons Implant Systems1060818-2026-25549
- BruxZir Full Contour Zirconia CrownJul 27, 2026InjuryPrismatik Dentalcraft, Inc.3011649314-2026-01161
- BRUXZIR FULL CONTOUR ZIRCONIA CROWNJun 30, 2026InjuryPrismatik Dentalcraft, Inc.3011649314-2026-00859
- BRUXZIR SCREW RETAINED CROWNFeb 16, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-00252
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
132 firms currently registered for this product code
Nobel Biocare Distribution Center Bv
Venlo Limburg, NL
Straumann Manufacturing, Inc.
Mansfield, TX, US
Institut Straumann Ag
BASEL Basel-Stadt, CH
Degudent Gmbh
HANAU Hesse, DE
Elos Medtech Pinol A/s
Goerloese Hovedstaden, DK
Nobel Biocare Ab
GOTEBORG Vastra Gotaland, SE
Shimmer Computerized Dental Technology Co.,ltd
Zhuhai Guangdong, CN
Implant Direct Sybron Manufacturing Llc
Thousand Oaks, CA, US
Ivoclar Vivadent Gmbh
Ellwangen Baden-Wurttemberg, DE
Biohorizons Implant Systems Inc.
BIRMINGHAM, AL, US
Jjgc Industria E Comercio De Materiais Dentarios Sa
Curitiba Parana, BR
Straumann Villeret Sa
VILLERET Bern, CH
Curitiba Esterilizacao De Materiais Medicos Ltda
Pinhais Parana, BR
Anthogyr
SALLANCHES Haute-Savoie, FR
Nobel Biocare Ab, Produktion
KARLSKOGA Orebro, SE
Terrats Medical, S.l.
Barbera del Valles Barcelona, ES
Medentika Gmbh
Calw Baden-Wurttemberg, DE
Sirona Dental Systems Gmbh
BENSHEIM Hesse, DE
510(k) clearances
8 clearances for this product code
- Institut Straumann AGDec 26, 2024
K233252 · Straumann CARES Visual and Nova Dental CAD
- Prismatik Dentalcraft, Inc.Mar 14, 2024
K231529 · CloudPoint FastDesign Chairside
- Rgorithm KoreaJul 18, 2023
K221107 · TRUST
- Exocad GmbHJul 21, 2021
K193352 · AbutmentCAD
- 3Shape A/SOct 7, 2020
K200100 · Abutment Design
- Dentsply SironaAug 19, 2020
K200191 · Sirona Dental CAD/CAM System with InLab Software
- Nobel Biocare ABMar 1, 2019
K181932 · DTX Studio design
- 3Shape A/SSep 6, 2016
K151455 · 3Shape Abutment Designer Software