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GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.

Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

The GEN5™ and GEN5+ Dental Implant System consists of a root form Endosseous dental implant, Endosseous dental implant abutment, and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

GEN5 and GEN5+ Dental Implants are supplied as a two-piece implant assembly for use in a two-stage or single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework or as a free-standing single tooth replacement. The standard GEN5 Implants are for use in a two-stage surgical procedure. The first surgery is for implant placement, and the second surgery is a few weeks prior to start of prosthetic rehabilitation. By the addition of an abutment of any type at time of implant placement, the implant functions as a one-stage, two-piece system.

The GEN5 Implant and GEN5+ Implant are the exact same dental implant (internal hex implant). The difference between the two is that the GEN5+ Implant includes a pre-attached hex engaging Extender Healing Abutment (accessory restorative component) screw-retained on the GEN5 Implant prior to packaging requiring only a single surgical procedure prior to prosthetic rehabilitation.

The top (coronal portion) of the GEN5 Implant body is with a 2.0mm straight neck. The depth gauge lines at 1mm, 2mm and 2.5mm (or at 1mm and 2mm on the ≤9mm length) from the top of the implant facilitate the placement level with the crest of the ridge or 1mm above the crest of the ridge for all implants except the 3.7mmD x 7mmL. The lower apical aspect of the Implant is tapered with double-lead progressively deeper buttress threads. Three cutting flutes extend over the tapered portion of the implant's body. The GEN5+ Implants offer the additional flexibility of a 2mm extender collar that can serve as the trans-mucosal collar of an abutment or can be removed for abutment connection directly to the top of the implant for vertical flexibility.

The GEN5 and GEN5+ dental implant body is available in five diameter sizes (3.7mm, 4.2mm, 4.7mm, 5.2mm, and 5.7mm) with two platform diameters (3.5mm or 4.5mm), and five lengths (7mm, 9mm, 11mm, 12.5mm, and 14mm). GEN5 and GEN5+ Implants have 2.0mmL of their coronal surface anodized with either a gold (3.5mmD) or a rose gold (4.5mmD) color for aesthetic purposes to help identify the two platform diameters while the remainder of the Implant has gone through a surface treatment (blasting) to create a microtextured surface roughness. These Implants (and the devices included in the packaging) are sold sterile. The GEN5 and GEN5+ Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The GEN5 and GEN5+ have an internal hex for abutment connection, which is designed to receive multiple abutment variations expanding its restorative options and allowing for the implant to be used for support of attachment-retained overdentures and cement-retained or screw-retained prostheses.

The GEN5 Implants are provided with an Internal Hex Carrier while the GEN5+ Implants (a GEN5 Implant pre-fitted with an Extender Healing Abutment) are packaged with an Extender Carrier and an Extender Carrier Fixation Screw.

The devices are sold in gamma irradiated sterile packaging which consists of an outer vial and an inner vial which is sealed with a threaded cap.

The Extender Carriers and Extender Carrier Fixation Screws are all manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The various devices included in the GEN5 and GEN5+ Dental Implant System (such as Endosseous dental implant abutments and various other prosthetic/restorative components) used to plan, implant, and support restorations for fully and partially edentulous patients are offered in compatible platform dimensions to enable a complete dental restoration.

The prosthetic and restorative components (Straight Contoured, Angled-Contoured, ASC, Multi-Unit Abutments, Titanium Multi-Unit Abutment Copings, Titanium Temporary, Healing, Extenders, Cover Screws, Transfers, and Analogs) are all manufactured from titanium alloy (Ti-6Al-4V ELI) and anodized.

The prosthetic components (PEEK Temporary Abutments) are all manufactured from polyetheretherketone (PEEK).

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.

Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:

1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:

Study Details (for a mechanical device):

2. Sample sizes used for the test set and the data provenance:

   • Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
   • The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
   • The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).

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

   • This question is not applicable as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.

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 mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

   • Not applicable. This device is a mechanical abutment, not an algorithm.

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

   • The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set exists for this type of device.

In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System:

Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392;

Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392:

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392;

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;

healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392;

healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398;

abutment screws for use with the angled abutments or healing caps.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a standalone study with defined performance metrics.

However, the document does contain information about performance data used to support the substantial equivalence claim. Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a structured table with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted and states that these tests demonstrate substantial equivalence to predicate devices, implying these tests met the necessary standards for such a claim.

Based on the "Performance Data" section (Page 6), the following can be inferred as the type of performance evaluation conducted:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test mentioned. For tests like sterilization, bacterial endotoxin, and shelf life, it generally states "samples" were tested.

• Sterilization: "all subject devices"
• Bacterial Endotoxin: "samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis"
• Shelf Life: "samples after 4 years of real time aging"
• Biocompatibility (PEEK and HA™® coating): Not specified.
• Mechanical Strength: "worst-case constructs" – implies a selection of representatives that challenge the design, but specific numbers are not given.

The data provenance is internal to the manufacturer (S.I.N.-Sistema de Implante Nacional S.A.) via non-clinical testing. While some data is "referenced from K170398 and K170392" or "leveraged from and provided in K170392," these are prior 510(k) submissions for the same manufacturer, indicating a history of internal testing. The tests are non-clinical, so "country of origin" from a clinical data perspective (e.g., patient demographics) is not applicable. The tests are prospective in the sense that they are conducted to evaluate the device, not retrospectively analyzing past clinical outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the document describes non-clinical engineering and laboratory testing to establish performance, not expert-based ground truth for clinical evaluation.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical engineering and laboratory testing, which typically involves quantitative results against specifications or predicate comparisons, not expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data were included in this submission." (Page 6).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable here. The device is a physical dental implant system, not an algorithm or AI system. The performance data presented are for the physical device components in a standalone context (e.g., testing the implant's strength, the coating's biocompatibility).

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is primarily engineering specifications, recognized standards (e.g., ISO, ASTM), and comparison to predicate device characteristics. For example, sterility is measured against a SAL standard, mechanical strength against ISO 14801, and biocompatibility against ISO 10993 series. The "truth" is whether the device meets these established technical benchmarks or is comparable to a predicate that has previously met them.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant system, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, there is no training set for a machine learning model.

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