Dental Implants
Dental implants, a key component of dental services and offerings, put a heavy focus on biocompatibility and reliability over time. Included within are designation systems and data sets, requirements for the instruments and accessories used in dental implant procedures, and test methods for torsion, loosening, and fatiguing. Together, these standards cover the entire process from development to implantation.
ANSI/ADA 173-2019
Designation System for Dental Implants
This standard provides a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the system describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5 to 8 which are employed when indicating a primary tooth.
ANSI/ADA 127-2018
Dynamic Loading Test for Endosseous Dental Implants
This standard specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes.
ISO 7405:2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
ISO/TR 18130:2016
Dentistry - Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants
ISO/TR 18130:2016 provides guidelines for a method to determine the extent of screw loosening of the metallic implant body/implant abutment joint of endosseous dental implants, such as two-part implants or multi-part implants under cyclic torsional loading. This test is most appropriate for evaluating new types of joints fixed using screw(s) and metallic connecting parts. This Technical Report provides a protocol for torsional cyclic torque on an implant body/implant abutment joint, but its intended use is for prefabricated implant bodies, implant abutments and, if appropriate, implant connecting parts that are made of metallic materials. It is not applicable to ensure the in vivo performance of endosseous dental implants and is not derived from observations of clinical failures. NOTE This Technical Report is not intended for use with temporary abutments.
ISO 19429:2015
Dentistry - Designation system for dental implants
ISO 19429:2015 provides a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the system describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5 to 8 which are employed when indicating a primary tooth. This information should be recorded by the responsible clinician in the patient's file and made available to the patient by the clinician(s) who provided the care.
ISO 16443:2014
Dentistry - Vocabulary for dental implants systems and related procedure
ISO 16443:2014 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from ISO 16443:2014. The following devices are also excluded from the scope of ISO 16443:2014. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions): epithesis implant; craniofacial implant; maxillofacial implant. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance: orthodontic implant.
ISO 16498:2013
Dentistry - Minimal dental implant data set for clinical use
ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s).
ISO 13504:2012
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.
ISO/TS 13498:2011
Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems
ISO/TS 13498:2011 establishes a method to determine the torsional yield strength and maximum torque of the implant body/connecting part joints of endosseous dental implant systems. This test is most appropriate for evaluating new types of joints and connecting parts, as well as new materials. ISO/TS 13498:2011 provides a protocol for torsional loading of an implant body/connecting part joint. It is not applicable for predicting the in vivo performance of an endosseous dental implant system and it is not derived from observations of clinical failure.
ISO 10451:2010
Dentistry - Contents of technical file for dental implant systems
ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.
ISO 11953:2010
Dentistry - Implants - Clinical performance of hand torque instruments
ISO 11953:2010 describes a classification system for hand-held torque wrenches intended for clinical use. It specifies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. Test methods are described, and marking and labelling requirements specified.
ISO 14801:2016
Dentistry - Implants - Dynamic loading test for endosseous dental implants
ISO 14801:2016 specifies a method of dynamic testing of single post endosseous dental implants of the transmucosal type in combination with their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. This International Standard is not a test of the fundamental fatigue properties of the materials from which the endosseous implants and prosthetic components are made. This International Standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments. While ISO 14801:2016 simulates the functional loading of an endosseous dental implant under worst case conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.
ISO/TR 11175:1993
Dental implants -- Guidelines for developing dental implants
Provides general guidelines, principles and concepts relevant to the production of a given type of dental implant; does not aim to define the ideal dental implant. Includes technical aspects and biological aspects.
