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510(k) Data Aggregation
(256 days)
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
SD Implant System consist of below:
Fixture
- SD Bone Level Fixture
Abutment - Cover Screw
- Healing Abutment
- Scan Healing Abutment
- Scan Healing Abutment Screw
- Cemented Abutment
- Angled Abutment
- Master Fix
- Master Fix Screw
- Digital Abutment
- Temporary Abutment
- Multi Abutment
- Multi Angled Abutment
- Abutment Screw
- Multi Scan Healing Cap
- Multi Scan Healing Cap Screw
- Multi Master Fix
- Multi Master Fix Screw
- Multi Ti Cylinder
- Multi Digital Cylinder
- Multi Temporary Cylinder
SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment, Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder)
This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function.
An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091.
SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091)
SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only.
The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations.
For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are:
Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only.
The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a twopiece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
The SD Implant System is intended for single use only. The Abutments are made of Ti-6AI-4V Eli (Conforming to ASTM F136) The SD Implant System connections compatible with NB 1 SA Implant System, NB Implant System and NB Mini Implant System
The provided text is a 510(k) summary for a dental implant system (SD Implant System) and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in the format typically used for performance studies of AI/ML-enabled devices.
Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.
The document details the device's components, materials, dimensions, indications for use, and a comparison to predicate devices, along with non-clinical performance data like biocompatibility, sterilization validation, shelf-life, and mechanical testing (ISO 14801). It does not contain information about:
- Acceptance Criteria for AI/ML performance: The document is for a physical dental implant system, not a software/AI device.
- Reported device performance for AI/ML: There's no AI component described.
- Sample size for test set and data provenance: Not applicable to this type of device submission.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for ground truth: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (pathology, outcomes data, etc.): Not applicable in the context of AI. Ground truth here refers to engineering specifications met by physical testing.
- Sample size for training set/How ground truth for training set was established: Not applicable, as there's no AI/ML training involved for a physical implant.
The document primarily focuses on demonstrating that the physical dental implant system meets established performance standards and is comparable to previously cleared devices through non-clinical testing.
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(366 days)
CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.
CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.
CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.
The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.
Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.
However, I can extract information related to the device's performance through non-clinical testing.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin Test | According to USP and ANSI/AAMI ST72:2011. Testing limit of 20 EU/device for blood contacting and implanted device. | Confirmed that the endotoxin test reagent (PTS cartridge) and laboratory environment were suitable, meeting endotoxin standards and established criteria. Implies performance within the accepted limit. |
| Fatigue Testing | According to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Objective: Confirm permanent restoration of the implant without failure. | Performed on the subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure. The language "to confirm covering permanent restoration of the implant without failure" implies successful completion meeting the standard. |
| Surface Analysis | Not explicitly stated as a separate acceptance criterion but is part of material characterization. | SEM & EDS analysis showed surface roughness leading to a macroroughness and no other impurity on the surface of the final product. This indicates the desired surface characteristics were achieved. |
| Gamma Sterilization | According to ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013, and ISO 11137-3:2006. Objective: Acceptable range of densities of other product in carrier and confirm process stability. | Evaluation showed an acceptable range of densities of other products in the carrier and confirmed process stability. Concluded that the packaging with gamma sterilization of the subject device is equivalent to predicate/reference devices, with a shelf life of 5 years. |
| End User Sterilization | According to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010/A4:2013. | Performed according to the stated standards. The implicit result is that it meets the requirements for end-user sterilization. |
| Biocompatibility Testing | According to ISO 10993-1:2018 and FDA Guidance Document "Use of International Standard ISO 10993-1...", and ISO 10993-5:2009. | Performed for each subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices, which includes assurance of biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
- Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.
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 device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is non-clinical bench testing against established 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:
Not applicable. This is a dental implant, not an AI/diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental implant, not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set."
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