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The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed 11 TX 3.5S and OsseoSpeed "M TX 4.0S implant fixtures.

All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.

· IMPLANOVA® BONE LEVEL IMPLANTS Narrow Medium: 3.5mm Diameter x 10mm Length Narrow Long: 3.5mm Diameter x 12mm Length Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length

Standard Short: 4.5mm Diameter x 8mm Length Standard Medium: 4.5mm Diameter x 10mm Length Standard Long: 4.5mm Diameter x 12mm Length Standard XLong: 4.5mm Diameter x 14mm Length

Wide Short: 5.5mm Diameter x 8mm Length Wide Medium: 5.5mm Diameter x 10mm Length Wide Long: 5.5mm Diameter x 12mm Length

· IMPLANOVA® ALL-IN-ONE IMPLANTS Slender Medium: 3.0mm Diameter x 10mm Length Slender Long: 3.0mm Diameter x 12mm Length Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length

The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.

Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

Implanova® Bone Level Abutments offer the following models.

· IMPLANOVA® BONE LEVEL ABUTMENTS

Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height

Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height

Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height

The system also offers Healing Caps and Cover Screws.

This document is a 510(k) Pre-market Notification for the Implanova® Dental Implant System. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria or a study proving the device meets specific performance criteria with numerical results for the device itself (Implanova®). Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, intended use, and non-clinical testing for safety and appropriate material and manufacturing characteristics.

Here’s a breakdown of the information that is available within the provided text, and what is not present based on your request:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the format requested. The document asserts that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices" (Pages 11 and 12), and that non-clinical testing "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (Page 17). However, the specific acceptance criteria for these tests (e.g., minimum fatigue strength in MPa or N) and the numerical results achieved by the Implanova® device are not listed. The document focuses on similarity to predicate devices rather than meeting discrete performance metrics presented in a table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The document lists types of non-clinical tests but does not specify the sample sizes used for these tests, nor the data provenance. These are typically details found in the full test reports, which are not included here.

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 information is not applicable/provided. The document describes non-clinical, laboratory-based testing (e.g., fatigue, sterilization, cytotoxicity, SEM/EDS) rather than clinical studies requiring expert review of data for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided. As above, this pertains to clinical study design and human interpretation of results, which is not described here.

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 information is not applicable/provided. This document describes an endosseous dental implant system, which is a physical medical device, not an AI-assisted diagnostic or decision support system that would involve human readers or AI improvement metrics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided in the context of clinical "ground truth." The ground truth for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 14801 for fatigue testing, ISO 11137-1 for sterilization).

8. The sample size for the training set:

This information is not applicable/provided. As this is a physical medical device, there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established:

This information is not applicable/provided. As above, there is no "training set."

Summary of available information related to performance and predicate devices:

The document primarily demonstrates substantial equivalence by comparing the Implanova® device to several predicate devices.

Key similarities highlighted for Implanova® Bone Level Implants (compared to BioHorizons Tapered Internal Plus, BioHorizons Internal Implants, U fit Dental Implant System):

• Intended Use: Same intended use (endosseous implantation in mandible and maxilla for artificial root structure, single/multiple missing teeth, support prosthesis, immediate loading when primary stability achieved).
• Operating Principle: Same.
• Basic Design: Incorporates same basic design (self-tapping, bone-level type implant, micro-threaded implant collar, tapered implant body).
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment.
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.
• Size Range: Similar (e.g., Diameter: 3.5mm, 4.5mm, 5.5mm; Length: 8mm, 10mm, 12mm, 14mm).

Key differences and justification for substantial equivalence despite differences:

• Micro-machined grooves vs. Micro threads: Laser-Lok® micro-machined grooves on predicates vs. micro threads on Implanova®. Justification: "functionally identical" as osteocytes cannot differentiate microscopic differences for osseointegration.
• Flute Lengths: Implanova® has longer flute lengths. Justification: "more tapping edges simply ease the tapping processes but functions the same."
• Twist Direction of Vertical Flutes: Implanova® has a minor left-hand twist (18mm pitch) vs. straight or slight right-hand twist on predicates. Justification: "only slightly increases the sharpness of the edges... and passively guides the swarf materials to consolidate... should not render the device NSE."
• Partial Surface Treatment: Implanova® has partial surface treatment (apical 5mm untreated) vs. modified throughout the implant body on predicates. Justification: Untreated apical area maintains sharpness for cutting bone; surface treatment is not a requirement for osseointegration.
• Fatigue Test Result: The document states that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices." (No numerical results are provided in the excerpt).

Key similarities highlighted for Implanova® All-in-One 3.0mm Implants (compared to Zimmer One-Piece Implant System, NobelDirect 3.0):

• Intended Use: Similar indications for support and retention of fixed single tooth and fixed partial dentures in specific mandibular/maxillary incisor regions, with immediate loading when good primary stability is achieved and appropriate occlusal loading.
• Design & Size: 3.0mm diameter.
• Connection Type: N/A (one-piece design).
• Basic Design: Self-tapping, tissue-level type implant, micro-threaded implant collar, tapered implant body.
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI) (NobelDirect uses CP Titanium grade 4).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment (Zimmer uses Hydroxyapatite blast media, NobelDirect uses TiUnite).
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.

Key differences and justification for substantial equivalence despite differences:

• Microthreads: Implanova® has microthreads vs. lack of microthreads on predicates. Justification: "only slightly increase the surface area... insignificant deviation... does not render the subject device NSE."
• Flute Lengths, Twist Direction, Partial Surface Treatment: Similar justifications to the bone-level implants regarding these differences.
• Surface Treatment Material: Implanova® uses calcium phosphate blast media; predicates use Hydroxyapatite or TiUnite. Justification: "chemical analysis data... supports that the blast media used for the subject device does not alter surface chemical compositions."

Non-Clinical Testing Performed (Page 17):

• Fatigue Testing (ISO 14801)
• 3rd Party Compatibility
• Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2)
• Shelf-life Validation (ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929)
• Cytotoxicity Testing (ISO 10993-5)
• SEM/EDS Chemical Surface Analysis

These tests are stated to have "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."

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Intended Use for Two-Piece Implant Systems

• For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis
• For single tooth or multiple unit prosthesis .
• For single stage or two stage surgical procedure .
• For immediate placement and immediate function when multiple units are splinted and for . single units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.
• Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. .
• . Taper Hex Implant System is compatible with NobelActive implants and prosthetics
• Double Hex Implant System is compatible with Astra double hex implants and prosthetics .
• Square Taper Implant System is compatible with Straumann Bone-Level implants and . prosthetics

Intended Use for One-Piece Implant System

• For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis
• For single tooth or multiple unit prosthesis ●
• For single stage surgical procedure .
• For immediate placement and immediate function when multiple units are splinted and for . single units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. In edentulous cases four or more implants must be used
• Overdenture Implants are intended for support of removable prosthesis. .

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained , screw retained and overdenture-type restorative options. The implants and abutments are made out of Ti6Al4V titanium alloy and have an internal anti-rotational geometry or have a one-piece design with the abutment portion being an integral part of the implant. The device also includes exempt accessories such as laboratory analogs and drivers for insertion of the implants. and The activFluor surface treatment of the implants is the same as on Blue Sky Bio's predicate devices and is performed by blasting the surface and chemically etching to enhance the surface roughness for apposition of bone to the implant surface. The implants and components are supplied sterile or not sterile and are labeled accordingly.

The provided text describes the "Blue Sky Bio Dental Implant System" and its modifications. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and results in the way typically seen for AI/ML-driven medical devices.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as it pertains to a traditional medical device (dental implants). There is no mention of an algorithm, AI, human-in-the-loop, or a test set with ground truth established by experts.

However, I will extract the information that is available and indicate when information is not present.

Acceptance Criteria and Device Performance for Blue Sky Bio Dental Implant System

This device is not an AI/ML device, so typical performance metrics like sensitivity, specificity, or AUC are not applicable, nor are direct comparisons of human performance with and without AI. The acceptance is based on demonstrating substantial equivalence to predicate devices through material, technological, and safety comparisons, as well as performance testing for compatibility and fatigue.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. This is a traditional medical device (dental implant). The "test set" and "data provenance" as understood in AI/ML studies are not relevant here. Performance was assessed through compatibility and fatigue testing of the physical device, not on a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a traditional medical device. Ground truth, in the context of expert review of data, is not established for this type of device submission. The assessment relies on engineering and material standards, and clinical experience with predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a traditional medical device. No adjudication method for a test set of data is mentioned.

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 traditional medical device. No AI assistance or human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a traditional medical device. There is no algorithm or standalone performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this device, ground truth as typically understood in AI/ML studies (e.g., confirmed diagnoses) isn't directly relevant. The "truth" or acceptance is based on:

• Compliance with manufacturing specifications.
• Material properties meeting standards.
• Mechanical performance (compatibility, fatigue) meeting or exceeding predicate device performance and industry standards (e.g., ISO 14801).
• Demonstration of substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.

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The Tapered Screw-Vent®, Screw-Vent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.

The purpose of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw-Vent (K013227), AdVent (K011245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP-1 surface. There is no significant difference in design or materials between the implants in this submission and the previously cleared implants from Zimmer Dental.

The provided document describes the 510(k) premarket notification for the Zimmer Dental Implants - Immediate Loading Indication. It is primarily a declaration of substantial equivalence to previously cleared devices, rather than a detailed study demonstrating performance against specific acceptance criteria for a novel device.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted from this document, as it focuses on demonstrating equivalence rather than a de novo performance study.

Here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The basis for clearance is substantial equivalence to predicate devices. The "performance" reported is that the "Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices":

• Same intended use
• Same operating principle
• Same basic design
• Same materials
• Packaged and sterilized using the same materials and processes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) for substantial equivalence based on product design and material similarities to previously cleared devices, not a performance study with a test set of data.

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. There is no mention of a test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set or adjudication process.

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/software device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (dental implants), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a learning algorithm or a study requiring data collection for training.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary based on the provided document:

The Zimmer Dental Implants - Immediate Loading Indication received 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices (Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Implants, and Nobel Biocare TiUnite Dental Implants).

The "acceptance criteria" and "performance" described are qualitative similarities in:

• Intended use
• Operating principle
• Basic design
• Materials
• Packaging and sterilization methods

No specific clinical studies with defined quantitative acceptance criteria, test sets, or expert evaluations are detailed in this 510(k) summary for the immediate loading indication, as the submission relies on the established safety and effectiveness of the predicate devices.

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