Search Results
Found 2 results
510(k) Data Aggregation
(203 days)
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the Ø3.30 Provata implants is limited to replacement of maxillary and mandibular lateral and central incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
This submission includes fully threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two diameters: Ø3.30 and Ø4.07 mm. The Ø3.30 implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12° from orthogonal to the long axis of the implant). Both the Straight and Co-Axis versions are available in fully roughened and 3 mm machined coronal section configurations. The Ø3.30 Straight and Co-Axis implants are each provided in in one prosthetic diameter (2.90 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.
The Ø4.07 implants subject to this submission are provided in length 6.4mm and as Straight (0°) implants only. The Ø4.07 implants are provided with a 3.575 mm prosthetic diameter and are available in fully roughened and 2 mm machined coronal section configurations.
This submission also includes: a Cover Screw (one design/size); Healing Abutments in two diameters (3.5 and 4.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Passive Abutments with a plastic burn-out component, in one size and two designs (engaging and non-engaging); PEEK Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Compact Conical Abutments in straight (0°) and 20°, angled design for multi-unit restorations: Narrow TIB Abutment Bases (engaging): and abutment screws.
Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration.
The Narrow and Compact Conical TIB Abutment bases are two-piece abutment designs, consisting standard premanufactured titanium alloy abutments for supporting a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient. The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.
All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (0.6mm or extended machined surface of 2 or 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634 and K180465. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The PEEK Abutments are manufactured from medical grade white Polyetheretherketone. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634, K180465, K193084 and K191250.
The provided text is a 510(k) summary for the Provata Implant System, which describes various dental implants and abutments. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond the general statement of "demonstrated fatigue performance of the subject device that exceeds its indication" based on ISO 14801 testing.
Therefore, most of the requested information cannot be extracted from the given text.
However, I can extract information related to performance testing and mention the lack of specific acceptance criteria and performance reports.
-
A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document states that "Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication." However, no specific acceptance criteria or quantitative performance results are reported. -
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 specified. The document only mentions "worst-case subject device constructs" were used for dynamic compression-bending testing.
- Data Provenance: Not specified.
-
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. The reported testing is non-clinical (mechanical fatigue testing), not related to clinical ground truth established by experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving adjudication. -
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
No, a multi-reader multi-case comparative effectiveness study was not done. This submission is for dental implants and abutments, and the non-clinical performance data focuses on mechanical and biological characteristics, not AI-assisted human reading. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance data is based on non-clinical mechanical testing and material equivalence. -
The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set. -
How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Ask a specific question about this device
(302 days)
Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.
Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.
Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.
Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).
The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:
- Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
- Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.
Here's a summary of the non-clinical performance and the basis of equivalence:
| Acceptance Criteria (Implied / Indirect) | Reported Device Performance (as stated in submission) |
|---|---|
| Fatigue Resistance (ISO 14801:2016 for Endosseous Dental Implants) | "Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry - Dynamic loading test for Endosseous Dental Implants and following FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (Implies satisfactory performance, no specific values given). |
| Biocompatibility (Cytotoxicity, per ISO 10993-1, 10993-5, 10993-12 for PEEK abutments) | "Cytotoxicity testing was performed on representative Temporary PEEK abutments (ASTM F2026-17) according to ISO 10993-1, ISO 10993-5, ISO 10993-12." (Implies satisfactory performance, no specific values given). |
| Packaging and Shelf-Life Stability | "The packaging for the subject device is the identical to the sponsor's own prior clearances as referenced in K102034 and K073713 in which accelerated aging testing was presented and leveraged for the subject devices." (Leveraged from predicate devices). |
| Sterilization (SAL of 10^-6 for sterile components) | "Test results and Sterilization Validations performed for the sponsor's own reference devices is also leveraged demonstrate suitable sterilization of the subject device sterile components with demonstration of a sterility assurance level (SAL) of 10-6." (Leveraged from predicate devices). |
| Pyrogenicity (LAL Endotoxin Analysis with testing limit of 20 EU/device) | "Pyrogenicity information provided is based on FDA Guidance... The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." (Implies compliance). |
| End-user Sterility Validation (ISO 17665-2 for PEEK abutments) | "End-user sterility validation was conducted according to ISO 17665-2 for subject Temporary PEEK Abutments." (Implies compliance). |
| MRI Safety (Magnetically Induced Displacement Force and Torque) | "Non-clinical worst-case MRI review to evaluate the metallic devices in the MRI environment using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance..." (Implies safety based on rationale and literature). |
| Clinical Safety/Effectiveness for Pterygoid Placement and Long Implants (Implied from clinical literature) | Clinical literature supports high success rates (e.g., 90.7% to 99%) for implants with similar dimensions and angulations in the pterygoid region and for the TILT procedure. The subject device's dimensions (10-25mm length, up to 45° angulation) fall within this window and are considered to not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
- Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.
4. Adjudication Method for the Test Set
Not applicable, as there was no dedicated clinical "test set" requiring adjudication.
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 dental implant system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (dental implant).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Ask a specific question about this device
Page 1 of 1