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510(k) Data Aggregation
(232 days)
Ticare Dental Implant Systems are endosseous dental implanted in the maxilla or mandble jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro implants are indicated to support permanently fixed restorations.
Ticare Inhex and Osseous implants of 6 mm length are in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.
The subject device is a dental implant system including threaded, root-form endosseous dental implants of various diameters and lengths, straight, angled, tapered, UCLA and ball abutments + retention cap as well as healing abutments, cover screws and retaining screws to secure prosthetic restorations. Implants are commercially pure Grade IV titanium except for InHex "Mini" and InHex Quattro "Mini" implants which are Grade V titanium alloy. Abutments and screws are grade V titanium alloy 6Al 4V. Retention cap is Vestakeep D4 R. All implants have an RBM surface. Abutments must be matched to implant design and platform size. Provisional and temporary abutments are for use no more than 2-3 months. Some Inhex abutment designs have a narrow neck alternative version to allow the clinician more choices for soft tissue management.
Osseous dental implants have an external hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13 and 15mm. Standard platform comes in diameters of 3.4, 3.75, and 4.25mm with lengths of 8, 10, 11.5, 13, 15mm (no 8mm in 3.4). There is also a 5.0 standard platform implant which comes in lengths of 6, 8, 10, 11.5, 13 and 15mm. Maxi comes in a diameter of 5.0mm and lengths of 6, 8, 10, 11.5, 13 and 15mm.
InHex dental implants have an internal hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13, 15mm. Standard platform comes in diameters of 3.75, and 4.25mm in lengths of 6 (not in 3.75), 8, 10, 11.5, 13 and 15mm. There is also a 5.0mm diameter implant in standard platform which only comes in a 6mm length. Maxi platform comes in a diameter of 5.0mm with lengths of 9, 10, 11.5, 13, 15mm.
The Osseous Quattro and InHex Quattro implant thread design enables them to be used in softer bone types. Osseous Quattro dental implants have an external hex connection in standard platform and are available in diameters 3.75mm and 4.25mm and lengths of 8, 10, 11.5, 13 and 15mm. InHex Quattro dental implants have an internal hex connection in mini and standard platform and are available in diameters of 3.3mm (mini platform), 3.75mm and lengths 8 (not in 3.3), 10, 11.5, 13 and 15mm.
Maxi platform implants and abutments are for use in the molar region. Mini platform implants and abutments are for use in lateral incisors and lower central incisors. Standard platform implants and abutments are for use in all tooth locations.
Osseous straight abutments come in six designs. Prepable abutments come in hexed with a gingival height of 2mm in standard, mini, and maxi platforms. Tall straight abutments come in hexed with gingival heights of 0.5, 1, 2, 3, 4mm in standard, mini and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard and mini platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.
Inhex straight abutments come in six designs. Prepable abutments come in hexed (not in mini) with a gingival height of 2mm in standard, mini, and maxi platforms. There is an additional hexed standard platform prepable abutment with a smooth exterior for cementing. Tall straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3, 4mm (4mm not in mini) in standard, mini and maxi platforms. There are also tall abutments with smooth surfaces for 5.0 implants which come in gingival heights of 3 or 4mm for both standard and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard, mini and maxi platforms. Multitask abutments comes in standard and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard and maxi platform. Inhex narrow neck tall straight abutments hexed and non-hexed come in mini platform with gingival heights of 2, 3mm and maxi & standard platforms with gingival heights of 2, 3, 4mm. Narrow neck short straight abutments hexed come in mini platform with gingival heights of 2, 3m and maxi & standard platforms with gingival heights of 2, 3, 4mm.
Osseous healing screws come in gingival heights of 2, 3, 4, 5, 6, 7mm (no 2mm in mini) in standard, mini, and maxi platforms. Osseous aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. There is an additional model in standard platform which has a tapered seating area.
Inhex healing screws come in gingival heights of 1, 2, 3, 4, 5, 6, 7mm (no 1mm in maxi) in standard and maxi platform. Inhex mini platform healing screws come in gingival heights of 3 or 4mm.There is an additional shorter design of healing screw for 5.0mm implants in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platform. Inhex aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. Narrow neck healing screws come in mini platform with gingival heights of 2, 3, 4mm and maxi & standard platform with gingival heights of 2, 3, 4, 5mm.
Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.
Inhex angled abutments come in 15° and 20° in gingival heights of 1, 3, 5mm for standard and maxi platforms and gingival height of 2mm for mini platform. For 5mm implants there is also a shouldered design of 15° and 20° abutment in gingival heights of 1, 3, 5mm for standard and maxi platforms.
Osseous UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, maxi and mini platforms. Osseous UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the gingival collar portion are not intended to be modified.
Inhex UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, and maxi platforms. Inhex UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the portion from the gingival collar portion to the bottom of the UCLA are not intended to be modified.
Osseous ball attachments in standard, maxi and mini platforms come in gingival heights of 1, 2, 3, 4, 5.5mm (no 1mm in maxi or mini). The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Inhex ball attachments in standard and maxi platforms come in gingival heights of 1, 2, 3, 4, 5.5mm. The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Osseous tapered abutments come in six different cone configurations on the top. 10° tapered abutments come in standard platform gingival heights of 2, 3, 4, 5mm with cone type 2, mini platform gingival heights 3, 4, 5mm cone type 1 and maxi platform gingival heights of 2, 3, 4, 5mm with cone type 3. 30° tapered abutments come in gingival heights of 4 or 5mm in standard platform with cone type 4 and maxi platform with cone type 5. Straight tapered abutments come in standard platform with cone type 6 in gingival heights of 2, 3, 4, 5mm. Angled tapered abutments come in standard platform with cone type 6 with 17° in gingival heights 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Inhex tapered abutments come in five of the possible six cone configurations. 10° tapered abutments come in standard platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2 and mini platform gingival heights 1, 2, 3mm in cone type 1. 10° tapered non-hexed abutments come in maxi platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2. 30° tapered abutments in cone type 4 gingival heights 1, 2, 3, 4, 5mm come in standard platform and non-hexed maxi platform. Straight tapered abutments in cone type 6 with gingival heights 2, 3, 4, 5mm come in standard and maxi platform. Angled tapered abutments with cone type 6 come in standard and maxi platform with 17° in gingival heights of 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Narrow neck 10° tapered abutments come in mini platform with gingival heights of 2, 3mm and standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 10° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments come in standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Healing abutments for tapered abutments include ones for 10° tapered abutment in standard and maxi platforms which is used with both Osseous and Inhex, angled tapered abutments for Osseous and Inhex, and 30° angled tapered abutment specific ones which fit Osseous maxi platform or Osseous standard and Inhex standard & maxi platforms.
Covers for provisional restoration of tapered abutments come in designs for 10° tapered abutments for Osseous and Inhex, mini and standard platform specific designs for 10° tapered abutments for Osseous and Inhex, and a design for 30° angled tapered abutments for Osseous and Inhex.
Posts for use with tapered abutments come in temporary and permanent restoration versions. Temporary ones come in standard and maxi platform versions for 10° and 30° tapered abutments which can be used with Osseous or Inhex. A temporary restoration post is also available for angled tapered abutments of Osseous or Inhex and an Osseous specific mini platform for 10° tapered abutments. Posts for permanent restoration come in versions for angled tapered abutments used for Osseous and Inhex, 10° tapered abutments used for Osseous and Inhex in standard platform, 30° tapered abutments used for Osseous and Inhex in maxi and standard platforms, non-hexed for 10° tapered abutments used for Osseous and Inhex in maxi platform, and non-hexed for 10° tapered abutment for Osseous mini platform. Titanium interfaces (shorter posts) are available for 10° and 30° tapered abutments for Osseous and Inhex, angled tapered abutments for Osseous and Inhex and 10° tapered abutments for Osseous mini platform.
The provided document is a 510(k) Premarket Notification Submission for Ticare Dental Implant Systems. It is a regulatory document seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets acceptance criteria.
Therefore, the requested information cannot be fully provided as it pertains to a study demonstrating performance against acceptance criteria, which is not the primary focus of this type of regulatory submission.
However, I can extract information regarding the non-clinical testing performed to support substantial equivalence, which serves as a proxy for demonstrating that the device meets certain performance specifications.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in a direct table format as acceptance criteria vs. specific quantitative performance values for each test. Instead, the document states that tests "met the criteria of the standards" or "demonstrated substantial equivalence."
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 for Test Set: Not explicitly stated for each individual test. The document mentions "worst-case scenario" for selection of implants/abutments for certain tests (e.g., shortest implant, largest abutments).
- Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Mozo Grau, S.A., based in Spain.
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):
This is not applicable as the document describes non-clinical bench testing, not clinical studies involving expert annotation or ground truth establishment in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is related to clinical interpretation and ground truth establishment, which did not occur in this non-clinical testing.
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 a non-clinical submission for a dental implant system, not an AI/software device involving human readers or comparative effectiveness studies of that nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is adherence to validated engineering and material standards for dental implants.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
However, I can summarize the non-clinical testing performed as evidence of meeting performance expectations (implicitly serving as 'acceptance criteria' in a regulatory context for substantial equivalence):
Summary of Non-Clinical Data / Testing Performed:
The Ticare Dental Implant Systems underwent various bench tests to demonstrate conformance to performance specifications and requirements, following the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of these tests were reported to have met the criteria of the standards and demonstrated substantial equivalence to the predicate devices.
Non-Clinical Tests Performed (and how they relate to acceptance):
| Test Category | Standard(s) / Description | Reported Performance / Outcome (Implicit Acceptance) |
|---|---|---|
| Mechanical / Durability | Fatigue testing: Under worst-case scenario in accordance with ISO 14801. | "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| Sterilization | Gamma Sterilization Validation: ISO 11137-1 and ISO 11137-2 (for devices delivered sterile). A Sterility Assurance Level (SAL) of 10^-6 was validated. | "The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device." |
| Steam Sterilization Validation: ISO 17665-1 (for devices delivered non-sterile, e.g., abutments, for end-user sterilization). Two steam sterilizations were conducted on worst-case abutments. | "The results showed equivalence to the predicate device." | |
| Shelf-Life | Shelf-life testing: ASTM F1980 (for accelerated aging of sterile barrier systems and medical devices). | "The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life is guaranteed up to 5 years, and the devices will function adequately as intended without any degradation during the shelf-life." |
| Packaging Integrity | Packaging Tests: ASTM F88 (seal strength of flexible barrier materials) and ASTM F1929 (dye penetration for seal leaks). | "The results guarantee shelf life up to 5 years under transport and storage conditions during the shelf-life of and USP . Performed on worst-case product. |
| Surface Characterization | SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy): To evaluate final cleaning after surface treatment. | "Implants are completely clean with no residues from the blasting processes on the implant surface, confirming the effectiveness of the cleaning process applied to Mozo Grau dental implants." |
| Dimensional & Mechanical (Short Implants) | Dimensional and mechanical tests: Performed for the shortest implant (6 mm long) from Mozo Grau's system, compared to K172576. This included Bone-to-Implant Contact (BIC) under bone level and 3mm resorption conditions, insertion/removal torque, and pull-out strength. | "All test results have indicated that the subject device is less critical, having more BIC in all conditions, higher insertion and removal torque and higher pull-out forces, indicating favorable substantial equivalence." (i.e., performance met or exceeded predicate/expectations, indicating safety and effectiveness comparable to existing devices). |
| MR Safety | Non-clinical worst-case MRI review: Evaluation of metallic Ticare devices in the MRI environment using scientific rationale and published literature. Rationale addressed magnetically induced displacement force and torque. | This review was performed to support the safety labeling related to MRI compatibility. (No direct "acceptance criteria met" statement, but the performance of the review supports the safe use.) |
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(165 days)
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
- · CONELOG® Implant System
- · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
- · TSXTM Implants
- · Tapered Screw-Vent Implant
- · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- · 3i OSSEOTITE®
- · Astra Tech OsseoSpeed™
- · Neodent Grand Morse
- NobelReplace® Trilobe
- · NobelReplace® Conical
- · Nobel Brånemark System®
- · Straumann BLX Implants
- · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
- · NobelActive® NobelParallel Conical
- Straumann® Bone Level
- · Zimmer Screw Vent® and Tapered Screw-Vent®
- · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
- · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
- · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- KDG Abutments, 4.8mm, max 30°
- · Keystone Multi Unit Abutment, 4.8mm, 0°
- · Medentika Multi Unit Abutments, 4.8mm, max 30°
- · EV Series Dentsply® Implants Astratech Osseospeed®
- · F Series Nobel Biocare NobelActive® NobelReplace® Conical
- · H Series Biomet 3i Certain®
- L Series Straumann Bone Level
- · N Series Straumann Soft tissue Level
- · R Series Zimmer Dental Tapered Screwvent®
- Medentika Multi Unit Abutments, 4.8mm, 0°
- E Series Nobel Biocare Replace™ Select
- · I Series Biomet 3i Osseotite®
- K Series Nobel Biocare™ Branemark
- · S Series Astra Tech OsseoSpeedTM
- · T Series Dentsply Friadent® Frialit/Xive®
- · MegaGen Multi Unit Abutments, 4.8mm, max 30°
- · Xpeed® AnyRidge® Internal Implant System
- AnyOne® Internal Implant System
- AnyRidge® Octa 1 Implant System
- AnyOne® External Implant System
- AnyRidge® Octa 1 Implant System
- AnyOne® Internal Implant System
- Rescue Internal Implant System
- MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
- · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
- · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
- · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
- · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
- Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
- Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
- · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
- · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
- SS SA Fixture Implants
- SA Implant System
- · ET US SSS Prosthetic System
- · Paltop Multi Unit Abutment, 5.0 mm, max 17°
- · Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
- Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
- · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
- · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°
The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.
- Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
- . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).
The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.
1. Table of Acceptance Criteria and Reported Device Performance
This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.
The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.
Table 1: Comparison of General Characteristics and Materials (summarized for clarity)
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Dental implant abutment for restoring chewing function in partially or fully edentulous jaws, attached to a minimum of two abutments. Specific compatible OEM abutment systems listed. | Substantially Equivalent. The subject device shares the same intended use. The primary difference is an expanded list of compatible OEM abutment systems. |
| Device Material | Titanium alloy Ti-6Al-4V (ASTM F136) | Meets/Substantially Equivalent. Manufactured from titanium alloy conforming to ASTM F136. |
| Design/Technology | CAD/CAM milling from single milling blanks | Meets/Substantially Equivalent. CAD/CAM milling from single milling blanks. |
| Design/Construction | Patient specific/machined | Meets/Substantially Equivalent. Patient specific/machined. |
| Sterility | Supplied Nonsterile | Meets/Substantially Equivalent. Supplied Nonsterile (to be sterilized by end-user). |
| Prescription/OTC | Prescription only | Meets/Substantially Equivalent. Prescription only. |
| Recommended Cleaning & Maintenance | Proper oral hygiene | Meets/Substantially Equivalent. Proper oral hygiene. |
Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)
| Design Parameters | Type A (Removable Prosthesis) Acceptance Criteria (Predicate) | Type B (Fixed Prosthesis) Acceptance Criteria (Predicate) | Type A (Removable Prosthesis) Reported Performance (Subject Device) | Type B (Fixed Prosthesis) Reported Performance (Subject Device) |
|---|---|---|---|---|
| Total Cylinders | 2-10 | 2-10 | 2-10 | 2-10 |
| Suprastructure Span Between Cylinders (mm) | 1-30 mm | 1-30 mm | 1-30 mm | 1-30 mm |
| Suprastructure Height (mm) | 3-12 mm | 3*-22 mm | 3-12 mm | 3*-22 mm |
| Suprastructure Width (mm) | 3.4-12 mm | 3.4**-12 mm | 3.4-12 mm | 3.4**-12 mm |
| Distal Cantilever Section (mm) | 0-15 mm | 0-15 mm | 0-15 mm | 0-15 mm |
| Cylinder Height (mm) | 0-4.6 mm | 0-4.6 mm | 0-4.6 mm | 0-4.6 mm |
| Cylinder Diameter (mm) | 4.5-8 mm | 4.5-8 mm | 4.5-8 mm | 4.5-8 mm |
*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.
2. Sample size used for the test set and the data provenance
The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.
- Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
- Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
- Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
- Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.
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 device is a physical dental suprastructure, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical dental suprastructure, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:
- Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
- Material specifications: Conformance to ASTM F136 for titanium alloy.
- Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
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(252 days)
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
Medentika series EV-Series, Implant system Dentsply® Implants - ASTRA TECH OsseoSpeed®, Implant diameter 3.6, 4.2, 4.8, Platform diameter 3.6, 4.2, 4.8
Medentika series F-Series, Implant system Nobel Biocare NobelActive - NobelReplace Conical, Implant diameter 3.5, 4.3, 5.0, Platform diameter NP 3.5, RP 4.3/5.0
Medentika series H-Series, Implant system Biomet 3i - Certain, Implant diameter 3.25, 4.0, Platform diameter 3.4, 4.1
Medentika series L-Series, Implant system Straumann - Bone Level, Implant diameter 3.3, 4.1, 4.8, Platform diameter 3.3, 4.1, 4.8
Medentika series N-Series, Implant system Straumann - Soft Tissue Level, Implant diameter 4.1, 4.8, Platform diameter 4.8, 6.5
Medentika series R-Series, Implant system Zimmer Dental Tapered Screw-vent, Implant diameter 3.3, 3.7, 4.1, 4.7, Platform diameter 3.5, 4.5
The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.
The provided document is a 510(k) premarket notification for "Multi-unit Abutments." This document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing. However, it does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in a diagnostic or interpretive context.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" outlined in the request (e.g., MRMC study, ground truth, expert consensus, sample size, effect size) are typically attributes of studies supporting AI/ML-driven medical devices that output a diagnostic or interpretive result. The device described in this 510(k) is a physical dental implant component, not a software or AI device.
Therefore, I cannot extract the requested information regarding AI/algorithm performance. The provided text outlines:
- Device Description: Multi-unit abutments are dental components screwed onto implants to support prosthetic suprastructures (e.g., bridges, bars).
- Performance Testing: This refers to mechanical and biological testing (e.g., dynamic fatigue, static strength, biocompatibility, sterilization) to ensure the physical device's safety and effectiveness, not the performance of an AI algorithm.
- Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new device is as safe and effective as previously cleared predicate devices through comparisons of indications for use, design, materials, and mechanical properties.
Specifically, here's why the requested information cannot be provided from the text:
- Acceptance Criteria/Reported Device Performance (Table): The document provides a table of "Technological Characteristics" comparing the subject device to predicates, but these are design and material specifications, not performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
- Sample Size and Data Provenance: Not applicable for an AI test set. The document discusses "test sets" in the context of mechanical fatigue and static strength tests (e.g., testing multiple abutment units), but not a dataset of images or patient cases for AI evaluation.
- Number of Experts/Ground Truth Establishment/Qualifications: Not applicable. There's no AI component requiring expert review for ground truth.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This device is a physical component, not an AI assisting human readers.
- Standalone Performance: Not applicable. There is no AI algorithm to evaluate in standalone mode.
- Type of Ground Truth Used: Not applicable. Ground truth for an AI would involve labeled data (e.g., disease presence/absence from pathology), which is irrelevant for a dental abutment.
- Sample Size for Training Set: Not applicable.
- Ground Truth for Training Set: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (dental abutments), which successfully demonstrates substantial equivalence based on engineering and biocompatibility standards. It does not involve any artificial intelligence or machine learning component, and thus the acceptance criteria and study details relevant to AI performance are absent.
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