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510(k) Data Aggregation
(192 days)
Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.
InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.
Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.
The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.
The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.
The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.
Not Found
The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.
Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.
To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.
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(391 days)
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered implants with Ø 3.7 mm Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme. SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICvantage tapered implants with Ø 3.0 mm Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation. The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
The provided text is a 510(k) Premarket Notification summary for dental implants, specifically the SICtapered and SICvantage tapered models. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a clinical study with acceptance criteria and performance metrics for an AI-powered diagnostic device.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states: "Non-clinical testing has been performed showing that the device (SICtapered & SICvantage tapered) performs as intended and are substantially equivalent to the predicate device (K173207)." The "tests" listed are related to biocompatibility, sterilization, shelf life, and mechanical fatigue, which are typical for medical devices like implants, not for an AI diagnostic tool.
However, I can provide a very limited interpretation based on the closest relevant information, acknowledging that it does not fit the typical pattern of an AI diagnostic device study.
Based on the provided document, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a dental implant, not an AI diagnostic device.
The primary "study" performed is a comparison to predicate devices and non-clinical testing (material, sterilization, mechanical). The "acceptance criteria" is that the new device performs "as intended" and is "substantially equivalent" to the predicates, meaning it does not raise new issues of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Meet ISO 10993 requirements | Passed. Biocompatibility confirmed through Cytotoxicity testing (ISO 10993-5 and -12) on Titanium Grade 4 (ISO 5832-2 / ASTM F67). "The biological safety of therefore considered to be satisfactorily demonstrated." |
| Sterilization Efficacy: Achieve SAL of 10^-6 | Passed. Irradiation sterilization validated to demonstrate SAL of 10^-6. |
| Shelf Life: Maintain performance for expected duration | Passed. 5-year device shelf life and packaging safety validated. |
| Mechanical Strength/Fatigue: Withstand dynamic loading | Passed. Dynamic loading test per EN ISO 14801 performed on worst-case SICtapered and SICvantage tapered devices. "Passed according to defined criteria with no unexpected results or significant deviations." |
| Substantial Equivalence to Predicate Devices: | Achieved. The devices are "substantially equivalent to the predicate device SICmax and SICvantage max respectively in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness." (Detailed comparison tables are provided in the source text, showing "Same" or "Substantially Equivalent" for various parameters like indications for use, body contact, material, design, surface treatment, etc.) |
2. Sample sizes used for the test set and the data provenance:
- Test Set (for non-clinical tests): Not explicitly stated in terms of patient or imaging data. The "sample size" here refers to the number of physical implants or test specimens used for lab testing (e.g., fatigue tests, biocompatibility tests). These numbers are not detailed in the summary document.
- Data Provenance: The data provenance for these non-clinical tests would be the specific accredited labs where the tests were performed. The document implies reliance on previous testing for predicate devices ("leveraged for the new device"), suggesting the data is retrospective in the sense of using prior test results. No information on country of origin of testing is provided, beyond the applicant being Switzerland-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes the testing of a physical medical device (dental implant), not an AI diagnostic algorithm that requires expert-established ground truth from medical images. The "ground truth" for these tests are objective, measurable physical and chemical properties (e.g., material composition, sterility levels, mechanical load limits).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to establish consensus ground truth from multiple human readers for diagnostic studies. The non-clinical tests described in this document rely on established scientific and engineering methodologies for their "ground truth."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This information pertains to an AI diagnostic device. The current document is for a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This information pertains to an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical/Physical/Chemical Measurements: The ground truth for the non-clinical tests (biocompatibility, sterilization, mechanical fatigue) would be derived from the objective results of the standardized laboratory tests rather than human interpretation or patient outcomes. For example:
- Biocompatibility: Absence of cytotoxic effects, reaction to specific extracts.
- Sterility: Sterility Assurance Level (SAL) measurement.
- Fatigue: Number of cycles to failure under specified loads.
8. The sample size for the training set:
- Not applicable. This document is not describing an AI model and therefore does not have a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set, this information is irrelevant to the provided document.
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(226 days)
Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
· Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.
The dental implant body are available in several diameter sizes (ranging from 3.2mmD - 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm).
The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.
The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.
The provided text is a 510(k) Summary for a dental implant device. It primarily details the comparison of the new device (Simply Iconic™ Implants) to predicate devices to establish substantial equivalence. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria or studies related to AI/ML performance.
Therefore, I cannot fulfill the request as the document does not contain the required information for an AI/ML powered device, such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth details, adjudication methods, or MRMC studies.
The document focuses on non-clinical testing for substantial equivalence of a physical dental implant, covering aspects like biocompatibility, fatigue, surface area analysis, pullout testing, insertion torque, sterilization, and shelf life.
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(315 days)
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- . Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (
The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.
The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.
The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.
The provided document is a 510(k) premarket notification from the FDA for dental implants. It details the device description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.
The performance data presented in the document solely pertains to physical and biological properties of the dental implants, such as fatigue testing, biocompatibility, surface area and bone-to-implant contact analysis, pull-out testing, insertion torque testing, sterilization validation, endotoxin testing, shelf-life validation, and distribution validation.
Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission for traditional dental implants.
The document explicitly states on page 7: "No animal or clinical studies were performed in support of this 510(k) notice." This further confirms the absence of the type of studies implied by your questions, which are typically found in submissions for diagnostic or AI-powered devices.
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(477 days)
NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.
NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
Implants with
NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.
The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).
Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).
The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.
Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.
Acceptance Criteria and Device Performance
This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.
However, based on the performance data listed, we can infer the types of performance evaluated:
| Performance Aspect | Implied Acceptance Criteria (relative to predicates) | Reported Device Performance (as implied by the summary) |
|---|---|---|
| **Clinical Performance (Short Implants |
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(149 days)
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
- · Two stage: MPI, ULT, API and CPI models
- One stage: OPI model
The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall be used within 32 degrees of parallelism for a splinted restoration.
This submission covers the changes related to Ditron's dental implants and abutments. The addition of more products' variations is to offer dental surgeons additional implant options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. Modification to the MPI Model -
The MPI features an expanding tapered implant body with double-thread selftapping design to gradually condense the bone.
The MPI model remained the same as cleared under K140727 except for the following modifications:
Length: 6mm (only with diameter of 4.2mm, 5.0mm and 6.0mm), Diameters: 3.3 (with lengths 8.0mm, 10mm, 11.5mm, 13mm and 16mm). The 'groove' between thread leads which is part of the MPI design in all dimension variations, was removed only at the OD 3.3mm design.
All MPI dimensions are detailed in section 7 of this 510(k) summary.
An additional implant type: ULT (Ultimate) -.
The ULT design is based on Ditron's cleared MPI model. The ULT features an expanding tapered implant body and a truncated-cone profile provides root-form morphology of the tooth root.
The implant has a self-tapping design and micro threads at the top of the implant. All ULT implant dimensions are detailed in section 7 of this 510(k) summary.
- An additional implant type: API (Advanced Precision Implants) -●
The API design is based on Ditron's cleared MPI model. The API features an expanding tapered implant body with double-thread self-tapping implant body and apex design. The design is intended for subcrestal placement.
The implant beveled collar shifts the implant-abutment junction inward, in order to achieve platform-switching configuration. Only the 6mm API model includes a 'groove' while the others do not. All API implant dimensions are detailed in section 7 of this 510(k) summary.
● An additional Abutment type: Milled Abutment -
The Milled Abutment design is based on Ditron's cleared Straight Abutments. The Milled Abutment allows the dentist to produce customized abutments (no additional angular correction).
No CAD/CAM design and fabrication is allowed for the Milled Abutment models. Only hand-milling or casting may be used for abutment modification.
● An additional Abutment type: Liberator Abutment -
The Liberator Abutment is an overdenture retention abutment. Its design is based on Ditron's cleared Ball Attachments. The Liberator abutments are used for tissue and implant support of overdentures. Typically with two or more relatively parallel implants. Liberator overdenture retention abutments provide firm retention and stabilization to the overdenture.
The Liberator Abutment is available is several length dimensions of 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0mm.
● Straight Multi-Unit Abutment -
Additional two lengths were added to Ditron's cleared Straight Multi-Unit abutments. These length dimensions are: 4.0mm and 5.0mm. All dimensions' variations of the straight Multi-Unit abutments are detailed in section 7 of this 510(k) summary.
All above described implants and abutments are made of biocompatible 6A1-4V-ELI Titanium grade.
The provided document is a 510(k) summary for Ditron's Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study for a novel device. As such, it primarily details non-clinical performance data and uses comparison to established predicate devices as its "proof".
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside reported numerical performance values in the way one might expect for a diagnostic AI device. Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of specific tests, and "performance" is stated as meeting these requirements.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993-1 and FDA Guidance for biological evaluation; satisfactory chemical characterization tests (cytotoxicity, leachables/extractables). | All tests completed with satisfactory results; no changes in body contact material. |
| Gamma Sterilization Validation | SAL of at least 10^-6; adherence to ISO 11137-2 and AAMI TIR33 (VDmax method). | Results supported SAL of at least 10^-6. |
| Steam Sterilization Validation | SAL of at least 10^-9; adherence to ISO 17665 (parts 1 & 2) and ANSI AAMI ST79 (overkill/half-cycle method). | Results supported SAL of at least 10^-9. |
| Surface Testing | Meeting Ditron's specifications via SEM/EDS and XPS tests. | All surface test results met Ditron's specifications. |
| Fatigue Testing | Adherence to ISO 14801 and FDA Guidance for Root-form Endosseous Dental Implants and Abutments; meeting test requirements for worst-case configurations. | The results met the test's requirements. |
| Implant-Bone Contact Analysis | Comparable to legally marketed predicate device. | Analyzed in comparison to legally marketed device. |
| Implant Surface Area Analysis | Comparable to predicate device. | Compared to the predicate device. |
| Comparative Pull-out Test | Acceptable performance compared to legally marketed device. | Performed for smallest implant with legally marketed device. |
| Shelf Life & Package Integrity | 5 years shelf life and package integrity; adherence to ISO 11607-1. | All tests met their acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance data for dental implants and abutments. Therefore, the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical studies with human participants does not apply directly. The "samples" used were the physical dental implant and abutment devices and their components which underwent various engineering and laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" for non-clinical engineering tests (like fatigue, sterilization, biocompatibility) is defined by established international standards (e.g., ISO, AAMI) and regulatory guidance documents (e.g., FDA Guidance). The experts involved would be engineers, material scientists, and microbiologists conducting the tests and interpreting results against these standards, rather than medical experts establishing a "ground truth" for patient data.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of medical images or patient outcomes. The non-clinical tests described here are objective laboratory measurements against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This question is not applicable. The document concerns dental implants and abutments, which are physical medical devices, not AI-powered diagnostic tools. Therefore, an MRMC study related to AI assistance for human readers does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable, as the device is a physical dental implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on international standards and regulatory guidance documents (e.g., ISO 14801 for fatigue, ISO 11137-2 for gamma sterilization, ISO 10993-1 for biocompatibility). These standards define acceptable limits and methodologies for demonstrating the safety and effectiveness of medical devices.
8. The Sample Size for the Training Set
This question is not applicable. The document describes pre-market notification (510(k)) for physical medical devices and their non-clinical testing, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of this 510(k) submission for dental implants and abutments.
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(176 days)
DenTack QUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw
The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
Here's an analysis of the acceptance criteria and supporting studies for the DenTack QUAD Dental Implants and Prostheses based on the provided document:
Acceptance Criteria and Device Performance for DenTack QUAD Dental Implants and Prostheses
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Fatigue Test (ISO 14801:2007) | Device performs at least as good as or better than the predicate device. | "The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." Tested on worst-case configuration (25° abutment with narrowest implant OD). |
| Evaluation of Minimal Rotation Torque after Placement and Expansion | Test results to be similar to and thus equivalent to the predicate device. | "The tests results found to be very similar and thus equivalent. The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." |
| Partially expanded QUAD Implant Reciprocating Effect Test | No additional damage to surrounding bone or implant from counterclockwise/clockwise rotation; performs similarly to reference device. | "The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device." |
| Material & Surface Characteristics | ||
| Surface Analysis (SEM) | - | Implant surface tested using SEM. (No specific acceptance criteria or performance metric beyond "tested" is stated). |
| Biocompatibility (ISO 10993-1, -5, -12) | No incompatibility potential or adverse biological effect. | "The chemical and biological tests have not revealed any incompatibility potential or any adverse effect." |
| Sterilization & Packaging | ||
| Gamma Sterilization Validation (ISO 11137-2, AAMI TIR 33 / ISO TS 13004) | Successful sterilization according to standards. | "Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method..." |
| Steam Sterilization Validation (ISO 17665-1:2006, ANSI AAMI ST79:2010, ANSI AAMI ST77:2013) | Validation results support SAL 10⁻⁶; IFU in-line with validation. | "The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results." |
| Shelf Life Validation (ISO 11607-1) | Sterility maintained for the device shelf life. | "This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life." |
| Functional/Clinical Equivalence | ||
| QUAD Removal after Expansion | The expandable design does not cause additional damage to the surrounding tissue. | "The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for most of the individual tests. It generally refers to testing being conducted "for Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and "in comparison to predicate device" or "legally marketed device."
- Fatigue Test (ISO 14801:2007): "Worst case configuration was selected." (Implies a specific combination of implant and abutment was tested, but no number of samples is given).
- QUAD Removal after Expansion: "artificial bone was used and a reference legally marketed device for comparison." (No number of samples or explicit provenance beyond "artificial bone").
- Evaluation of Minimal Rotation Torque: "artificial bone." (No number of samples).
- Partially expanded QUAD Implant Reciprocating Effect Test: "a legally marketed device with similar instructions for use." (No number of samples).
- Biocompatibility (ISO 10993-1, -5, -12): "final and sterilized products." (No number of samples).
- Sterilization and Shelf Life Validations: Not specified, but generally follow specific standards.
The data provenance is largely implied to be laboratory-based testing using in vitro models (e.g., artificial bone) and comparisons to existing devices, rather than in vivo or human data. There is no information regarding country of origin for the data other than the company being based in Israel. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
No direct mention of experts or their qualifications establishing "ground truth" for the test set is provided. The studies described are primarily engineering and laboratory performance tests against industry standards (e.g., ISO, AAMI) or in comparison to predicate devices, rather than clinical studies requiring expert consensus on outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests are primarily physical, chemical, and mechanical evaluations against defined standards and comparative performance with predicate devices, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document describes laboratory and engineering tests, not clinical studies involving human readers or cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical medical device (dental implants and prostheses), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the various studies is typically defined by:
- Industry Standards: Compliance with international standards (e.g., ISO 14801, ISO 10993 series, ISO 11137-2, ISO 17665-1, ISO 11607-1).
- Comparative Performance: The performance of legally marketed predicate devices or reference devices, establishing a benchmark for substantial equivalence.
- Defined Benchmarks/Thresholds: For tests like sterilization success (SAL 10⁻⁶) or fatigue limits implied by ISO standards.
- Qualitative Assessment: Such as "no additional damage" or "no incompatibility potential" demonstrated in material science or biological tests.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is for a physical medical device clearance, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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(206 days)
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.
This document is a 510(k) Pre-market Notification for a dental implant system called Z5m(t). It does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, AI performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone AI performance cannot be extracted from this document.
However, I can extract the general "performance data" that was submitted for this non-AI device:
Performance Data for Z5m(t) Dental Implant System (Non-AI device)
This device is not an AI/ML device, so much of the requested information (AI performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies) is not applicable. The document describes performance data for the dental implant itself, focusing on physical and biological aspects, not a diagnostic or prognostic AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device (dental implant) and not an AI algorithm, the "acceptance criteria" are related to product standards and validation rather than diagnostic performance metrics. Similarly, "reported device performance" refers to the validation results against these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance / Compliance |
|---|---|
| Sterilization Validation (according to ISO 14937: Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices) | Sterilization parameters have been validated to a Sterility Assurance Level (SAL) of 10-6. |
| Biocompatibility Evaluation (according to ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | No new biocompatibility testing was performed. The materials and manufacturing methods are identical to those used for the predicate device, which was previously evaluated for biocompatibility. |
| Static and Dynamic Compression-Bending Testing (according to ISO 14801: Dentistry - Implants -Dynamic fatigue test for endosseous dental implants) | The subject device does not represent a new worst-case in mechanical testing compared to the predicate. (Implies it meets or exceeds the predicate's performance). |
| Software Validation (Implicit for any embedded software, though not detailed) | Software validation was conducted (details not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of typical AI/ML test sets. The tests mentioned (sterilization, biocompatibility, mechanical) involve specific numbers of device units or biological assays per standard, but are not usually referred to as "test sets" in the AI sense.
- Data Provenance: Not applicable in the context of this type of device submission. The data would be generated in laboratories according to international standards (ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI device that requires expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI device that requires expert adjudication for a ground truth dataset.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no human reader comparative effectiveness studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would be established by physical and biological measurements against regulatory and industry standards (e.g., a device is sterile if it meets the SAL, it is biocompatible if it passes ISO 10993 tests, it is mechanically sound if it passes ISO 14801 fatigue tests).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm. No training set is used.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI algorithm. No training set or ground truth for a training set is relevant.
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