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K Number
K243255
Device Name
URIS Long Implant & Abutments
Manufacturer
TruAbutment Inc.
Date Cleared
2025-07-03

(261 days)

Product Code
DZE
Regulation Number
872.3640
Type
Traditional
Panel
DE
Reference & Predicate Devices
K232418,K200817,K231874,K172100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

URIS Long Implant & Abutments are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Description

URIS Long Implants are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile.

URIS OMNI Long Implants consist of two implant lines, the OMNI Straight and the OMNI Tapered. The OMNI Straight implant features straight walls, with smaller threads at the coronal end and larger threads at the apical end. The OMNI Tapered implant has a tapered wall with a single-thread design.

Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 – Ø 4.5 mm).

Both implant lines share the following diameters and lengths:

TypePlatformDiameter (Ø)Length (mm)
StraightNarrowØ 3.516, 18
StraightRegularØ 4.0 – 4.516, 18
TaperedNarrowØ 3.516, 18
TaperedRegularØ 4.0 – 4.516, 18

URIS OMNI Long Implants are compatible with the following abutments:

The abutments are provided non-sterile. All non-sterile products must be sterilized by the end user prior to use.

The AOT Angled Abutment, Multi-Unit Base, and Multi-Unit Temporary Abutment are packaged with their corresponding screw(s).

For convenience, the Multi-Unit Base and Multi-Unit Temporary Abutment are each supplied with two screws included in the package.

The abutments are designed for use with the two implant types submitted in this application. They are also compatible with the implants included in the K172100 URIS OMNI Implant system (Narrow: Ø3.5 mm, lengths 8.5–14.5 mm / Regular: Ø4.0–Ø6.5 mm, lengths 7.0–14.5 mm).

The AOT Straight and AOT Angled Abutments are compatible with the Base and Temporary Abutments included in this submission, as well as those previously cleared under K231874.

AI/ML Overview

The provided FDA 510(k) clearance letter for URIS Long Implant & Abutments does not contain information about acceptance criteria and study proving device performance as typically expected for AI/ML-driven medical devices. This submission is for a traditional dental implant system, and the clearance is based on substantial equivalence to predicate devices through non-clinical testing, primarily focusing on mechanical, material, and biocompatibility properties.

Therefore, many of the requested elements regarding acceptance criteria for device performance (e.g., sensitivity, specificity, AUC), study design (sample size, data provenance, ground truth establishment, expert adjudication), and AI/ML-specific study types (MRMC, standalone performance) are not applicable to this submission.

However, I can extract the information relevant to the type of device and submission, specifically the non-clinical acceptance criteria and the tests performed to meet them.

Acceptance Criteria and Supporting Study for URIS Long Implant & Abutments

As this FDA 510(k) pertains to a traditional dental implant and abutment system (URIS Long Implant & Abutments, K243255), and not an AI/ML device, the acceptance criteria and study details are focused on non-clinical performance, primarily demonstrating mechanical integrity, material compatibility, and safety through established engineering and biological standards, rather than diagnostic accuracy metrics.

The clearance is largely based on demonstrating substantial equivalence to previously cleared predicate devices through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (dental implants), the "performance" is demonstrated through engineering and biocompatibility testing rather than diagnostic accuracy. The acceptance criteria are implicitly meeting the requirements of the cited ISO and USP standards. The document doesn't provide specific quantitative "pass/fail" values for each test, but rather states that the device "met the criteria of the standards."

Acceptance Criteria CategorySpecific Test/EvaluationReported Device Performance
BiocompatibilityBacterial Endotoxin Testing (LAL) in accordance with USP and USPMet criteria of the standards
BiocompatibilityBiocompatibility testing according to ISO 10993-1Met criteria of the standards (Completed)
SterilizationSterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2Met criteria of the standards
Sterilization (End-user)End user sterilization Testing according to ISO 17665-1,-2Met criteria of the standards
Shelf-Life & Packaging IntegrityShelf-Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testingMet criteria of the standards
Mechanical IntegrityFatigue Testing according to ISO 14801:2016 and FDA Guidance (worst-case scenario)Met criteria of the standards (Addressed dimensional differences from predicates via this testing)
Material CharacterizationSEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysisMet criteria of the standards (Implicitly, as part of material verification)
Substantial EquivalenceComparison of Indications for Use, Material, Design, Dimension, Connection, Functions, and Surface Treatments to Predicate DevicesDemonstrated substantial equivalence

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

  • Sample Size: Not explicitly stated in terms of a "test set" as one would expect for an AI/ML device. The "sample size" would refer to the number of physical dental implants/abutments subjected to each non-clinical test (e.g., number of units for fatigue testing, number of samples for biocompatibility). These numbers are not detailed in the summary but would be standard for regulatory testing required by the ISO/ASTM standards cited (e.g., minimum of 5-10 samples for fatigue per condition).
  • Data Provenance: Not applicable in the context of patient data for diagnostic accuracy. The "data" originated from laboratory testing of the manufactured dental implants and abutments.

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

  • Not Applicable: This clearance is based on non-clinical engineering and biological safety tests (e.g., fatigue strength, sterility, biocompatibility), not on the interpretation of medical images or patient data requiring expert consensus or ground truth establishment by clinical experts like radiologists.

4. Adjudication Method for the Test Set

  • Not Applicable: As there is no human interpretation of data for diagnostic purposes, there's no need for an adjudication process. Test results are objective measurements (e.g., force at failure, sterility present/absent).

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

  • Not Performed / Not Applicable: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This device is a physical dental implant, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

  • Not Performed / Not Applicable: This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

  • Engineering/Material Standards and Biological Safety Standards: The "ground truth" for this device's performance is established by the specified ISO and ASTM standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). These standards define acceptable performance limits for mechanical properties and biological responses.

8. Sample Size for the Training Set

  • Not Applicable: This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on established engineering principles and materials science.

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

  • Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.