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510(k) Data Aggregation
(169 days)
BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue.
The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration.
The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment:
- Scanner: 3Shape Trios 5 intra-oral scanner.
- Design Software: 3Shape Abutment Designer Software, K151455.
- Zirconia Material: sagemax® NexxZr zirconia, K130991.
- CAM software: hyperDENT® Classic
- Milling machine: imes-icore® CORiTEC 150i Pro milling machine
- Cement: 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476.
The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.
The provided document is an FDA 510(k) clearance letter for the Conical Ti Base abutments.
*Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about any clinical studies, sample sizes, expert ground truth establishment, or AI effectiveness studies.
The letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:
- Identical intended use: Both the subject device and the primary predicate (K240187) are "intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations." The subject device adds the "digital dentistry workflow" aspect, which is equivalent to the secondary predicate (K231307).
- Similar or identical design and technological characteristics: This includes material composition (Ti-6Al-4V alloy for the titanium base, sagemax NexxZr zirconia for the superstructure), manufacturing methods, digital design software and hardware (for the zirconia superstructure), design limitations, usage, sterility, and biocompatibility.
The "Performance Data" section discusses:
- Reliance on predicate submission data for non-clinical aspects like mechanical testing, biological safety, steam sterilization, and magnetic resonance testing, as there were no changes since the previous clearance (K240187).
- New testing was conducted to support the CAD/CAM design and use within a digital dentistry workflow, demonstrating controls of this workflow and that the final abutment is equivalent to those produced by the validated milling center cleared in K240187. This involved assessing abutment angulation, diameter, height, wall thickness, tolerances, and part quality.
- Surface characterization (SEM and EDX) was done on the titanium base component to ensure no residual blast media.
- No clinical data were included in this submission.
Therefore, I cannot provide the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, or AI effectiveness. The clearance is based on non-clinical data and substantial equivalence to existing devices.
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(8 days)
This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:
- Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
- Luting metal inlays, onlays or crowns;
- Luting pre-fabricated and cast post cementation
- Luting orthodontic appliances
- Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram
3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.
The provided text describes the acceptance criteria and a study demonstrating that the device, RelyX™ Luting Plus Automix, meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by comparing the performance of the new device (RelyX™ Luting Plus Automix, referred to as Lexus 2) against a legally marketed predicate device (3M™ ESPE™ RelyX™ Luting Plus Cement, K022476). The reported device performance is indicated by "pass" for all tested properties, signifying that Lexus 2 met or exceeded the design specifications, which are implicitly acceptable as they are compared to a predicate device.
| Properties | Method | Lexus 2 Design Specification | Lexus2 Ave and Predicate (K022476) Performance |
|---|---|---|---|
| Flexural strength (FS) (MPa) | ISO 9917-2 | ≥ 10 MPa | pass |
| Radio-opacity (mm of Al) | ISO 9917-2 | ≥1.0mm of Al | pass |
| Adhesion to dentin (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to enamel (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Metal (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lava™ (MPa) zirconia | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to composites | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to amalgam | 3M ESPE internal | ≥2MPa | pass |
| Adhesion to Titanium (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lithium disilicate (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Fluoride release (µg F/g) at 90 days | 3M ESPE internal | ≥500 | pass |
| Film thickness (microns) | ISO 9917-2 | ≤ 25 | pass |
| Work time (s) | 3M ESPE internal | ≥ 90s | pass |
| Set time (s) | 3M ESPE internal | <480s | pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual bench test. It mentions that the data is obtained from "Bench Test Data Comparison," and the methods used for certain tests are "ISO 9917-2" and "3M ESPE internal" methods.
The data provenance is from internal testing conducted by 3M ESPE. There is no mention of country of origin for the data or whether it was retrospective or prospective, but it implies a controlled laboratory environment designed to compare the new device to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study concerns the physical and chemical properties of a dental cement, evaluated through standardized bench tests and internal laboratory methods, rather than expert interpretation of medical images or patient data. Therefore, there is no "ground truth" established by experts in the context of medical diagnosis.
4. Adjudication method for the test set
Not applicable. This study does not involve human interpretation or subjective assessment that would require an adjudication method. The evaluations are based on predefined quantifiable metrics and established testing protocols.
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 a study involving human readers or AI assistance. It is a bench test comparison of the physical and chemical properties of a dental cement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device. It is a dental cement, and its performance is assessed through laboratory bench tests.
7. The type of ground truth used
The "ground truth" in this context is established by:
- International Standards: ISO 9917-2 for Flexural Strength, Radio-opacity, and Film Thickness. These standards define the methods and potentially acceptable ranges for these properties.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (RelyX™ Luting Plus Cement, K022476). The new device is considered substantially equivalent if its performance (as measured by design specifications and actual test results) is comparable to or better than the predicate's and meets the specified criteria.
- Internal 3M ESPE Specifications: For properties like adhesion, fluoride release, work time, and set time, "3M ESPE internal" methods and "Design Specifications" are used, implying established internal criteria and methods by the manufacturer.
8. The sample size for the training set
Not applicable. This is a bench test study for a physical product, not a machine learning model, so there is no training set in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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