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510(k) Data Aggregation
(0 days)
New Jersey 07940
Re: K253236
Trade/Device Name: G-Block
Regulation Number: 21 CFR 872.3690
Tooth Shade Resin Material
CLASS: Class II (Special Controls)
REGULATION NUMBER: 21 CFR 872.3690
Tooth Shade Resin Material
CLASS: Class II (Special Controls)
REGULATION NUMBER: 21 CFR 872.3690
larger structures could be milled on a disc (i.e. dentures) not on a block. |
| Classification | 21 CFR 872.3690
21 CFR 872.3770 | 21 CFR 872.3690 21 CFR 872.3770 21 CFR 872.3760 | 21 CFR 872.3690 21 CFR 872.3770
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.
G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.
G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.
G-BLOCK presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.
G-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.
G-BLOCK is low density making the prosthesis lightweight.
G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.
G-BLOCK has colour stability.
G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.
G-BLOCK is chemically inert.
G-BLOCK water absorption is 4 μg/mm³ and a solubility of 0.5 μg/mm². The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-BLOCK offers a durable and safety treatment.
G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.
The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.
G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.
When machined, Monochroma and Multichroma present a different visual effect:
-
Monochroma, is made of a pure colour matching the dentin.
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Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.
Both variants are presented in two sizes: 14 and 40.
G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).
G-BLOCK are provided non-sterile and as a single use device.
G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.
G-BLOCK should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.
N/A
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(1 days)
Trade/Device Name: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
Regulation Number: 21 CFR 872.3690
Tooth shade resin material
Model: CB21-A1/CB21-A2/CB21-A3/CB21-B1
Regulation number: 21 CFR 872.3690
VarseoSmile TriniQ
Classification Name(s): Tooth shade resin material
Regulation number: 21 CFR 872.3690
Dura-Crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Dura-Crown is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. Dura-Crown can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
The product should be used in combination with SHINING3D printer. It is stored in 500ml HDPE bottle. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by a photoinitiator contained in the resin. Automated printing of the resin in multiple layers, each light-cured before adding next layer, are post cured in the cure device. The product is intended exclusively for professional dental work.
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(175 days)
Dental cement
Classification Name: Cement, Dental
Device Classification: Class II, 872.3275/872.3690
- Class I, II, III, IV and V restorations
- Root surface restoration
- Core build-up
EQUIA LC ONE is a resin-modified glass ionomer dental restorative material which is intended to be used as a restorative filling material for direct restorations and or core buildups. The applicant device is provided as a powder/liquid formulation in a mixing capsule.
N/A
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(65 days)
K251946**
Trade/Device Name: G aenial Universal Injectable II
Regulation Number: 21 CFR 872.3690
Conditioner, Adhesive, Bracket And Tooth Conditioner, Resin
Device Classification: Class II, 872.3690
- Direct restorative for Class I, II, III, IV, and V cavities
- Fissure sealant
- Sealing hypersensitive areas
- Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel
- Blocking out undercuts
- Liner or base
- Core build-up
- Adhesive cementation of ceramic and composite veneers, inlays and onlays with a thickness (<2.0 mm) and translucency that enables the complete light curing of the cement
- Retention of aligner e.g. by fabrication of aligner attachments
G-ænial Universal Injectable II is a light-cured, nano-filled radiopaque composite resin filled in syringe. The device is used for the restoration of both anterior and posterior teeth, core build-up, adhesive cementation of ceramic and composite veneer, inlays and onlays, and build-up for transparent removable orthodontic retainers. The device is available in 9 shades.
This document is an FDA 510(k) clearance letter for a dental resin material, G-ænial Universal Injectable II. It is important to note that this is NOT an AI/ML medical device submission. Therefore, the information provided in the document focuses on the material's physical and chemical properties and biocompatibility, as compared to predicate dental materials.
The request asks for information typically found in submissions for AI/ML medical devices, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), details about test and training sets, expert consensus for ground truth, MRMC studies, and effect sizes of AI assistance. Since this is a dental material, these types of studies are not relevant and are not present in the provided document.
Therefore, the following response will adapt the requested sections to the context of this dental material, explaining what information is available and what is not, given the nature of the device.
Acceptance Criteria and Device Performance for G-ænial Universal Injectable II
The acceptance criteria for G-ænial Universal Injectable II are based on established ISO standards for dental materials and FDA guidance for composite resin devices. The "study that proves the device meets the acceptance criteria" refers to the Performance Bench Tests and Non-Clinical Performance Testing detailed in Section 7 and 8 of the 510(k) summary. These tests assess the physical, chemical, and biological properties of the material.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Complies" with specific quantitative or qualitative thresholds defined by the standards (e.g., ISO 4049, ISO 6874). The document reports that the device Complies with all listed requirements.
| Property | Acceptance Criterion (Requirement from Standards/Guidance) | Reported Device Performance (G-ænial Universal Injectable II) |
|---|---|---|
| Film thickness | 50 µm or less. | Complies |
| Sensitivity to light | Remain physically homogeneous. | Complies |
| Depth of cure (ISO 4049) | Opaque shade; 1.0 mm or moreOther shade; 1.5 mm or more | Complies |
| Flexural strength | 80 MPa or more. | Complies |
| Water sorption | 40 µg/mm³ or less | Complies |
| Solubility | 7.5 µg/mm³ or less | Complies |
| Shade of restoration materials | Closely match the shade of the shade guide. Shall be evenly pigmented. | Complies |
| Colour stability after irradiation and water sorption | No more than slight change in colour. | Complies |
| Radio-opacity | Equal to or greater than the radio-opacity of the same thickness of aluminium. | Complies |
| Depth of cure (ISO 6874) | 1.5 mm or more | Complies |
| Compressive strength | 100 MPa or more. | Complies |
| Elastic modulus | Equivalent or more than predicate device. | Complies |
| Surface hardness | Equivalent or more than predicate device. | Complies |
| Adhesive bond strength | Equivalent or more than predicate device. | Complies |
| Filler particle size | 0.01 - 0.5 μm (as per product description) | This is a characteristic, not an acceptance criterion, but the device meets this range. |
2. Sample Size Used for the Test Set and Data Provenance
For a dental material, the "test set" refers to the samples of the material manufactured and subjected to the performance bench tests and biocompatibility assessments.
- Sample Size: The document does not specify the exact number of samples (e.g., number of specimens for flexural strength, number of animals for biocompatibility tests). It simply states that "Performance testing includes" and "A biocompatibility assessment was completed."
- Data Provenance: The data provenance is internal to the manufacturer (GC America, Inc.) and derived from laboratory testing of the material according to international ISO standards and FDA guidance documents. There is no indication of "country of origin of the data" in the sense of patient data, nor is it a retrospective or prospective study in the clinical trial sense. These are laboratory-based material characterization tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to a dental material submission. The "ground truth" for material properties is established by the standardized test methods themselves (e.g., ISO 4049 defines how depth of cure is measured). There are no "experts" establishing ground truth in the sense of clinical interpretations or diagnoses. The expertise lies in adhering to the established test protocols and analyzing results accurately by qualified laboratory personnel.
4. Adjudication Method for the Test Set
This concept is not applicable for dental material performance testing. Adjudication methods (like 2+1, 3+1 consensus) are used in studies involving human interpretation of images or clinical outcomes, typically for AI/ML device validation. Here, tests are quantitative measurements of physical/chemical properties or biological responses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improving with AI vs Without AI Assistance
This question is not applicable. G-ænial Universal Injectable II is a dental restorative material, not an AI-assisted diagnostic or therapeutic device. There are no "human readers" involved in interpreting its performance, nor does it assist human readers. Therefore, no MRMC study was performed, and no effect size on human reader improvement with AI assistance can be reported.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. G-ænial Universal Injectable II is a physical dental material, not an algorithm. There is no "standalone performance" of an algorithm. Its performance is measured directly through laboratory tests of its inherent material properties.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For dental materials, the "ground truth" is based on:
- Standardized Test Methods: Adherence to established ISO standards (e.g., ISO 4049, ISO 6874, ISO 10993) defines the "truth" for material properties like flexural strength, depth of cure, water sorption, and biocompatibility.
- Predicate Device Comparison: Performance is also evaluated in comparison to predicate devices, where "equivalence" often serves as a benchmark for acceptance.
There is no "expert consensus," "pathology," or "outcomes data" in the sense of human diagnostic performance or clinical trial results, as this is a pre-market notification for a material.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" for a dental material in the context of machine learning. The material itself is manufactured, and specific properties are tested for quality control and regulatory submission.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set.
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(63 days)
Classification Name: Root canal filling resin
- Product Code: KIF
- Classification regulation: 21 CFR 872.3690
- Furcation or root perforation treatment via canal
- Furcation or root perforation treatment via surgical
- Internal reabsorption treatment via canal or surgical
- External reabsorption treatment
- Retrofilling in parendodontic surgery
- Direct and Indirect pulp capping
- Apexification
- Apexogenesis and Pulpotomy
One-Fil Putty Injectable is a premixed material intended for permanent root canal filling. It is based on a tricalcium silicate composition, which undergoes setting and hardening in the presence of moisture.
The product is packaged in a paper box with four syringes in a vinyl packaging, and the contents in the glass syringe are white paste type.
This FDA 510(k) clearance letter and summary are for a dental material, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment, training set details, and expert qualifications) are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets them.
Acceptance Criteria and Device Performance for One-Fil Putty Injectable (K251884)
The "One-Fil Putty Injectable" is a dental root canal filling material. Its acceptance criteria are based on conformance to international standards for dental materials, specifically ISO 6876, and comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by conformance to ISO 6876 and the performance of the predicate device (One-Fil Putty, K243353). The reported performance of the subject device is directly compared to the predicate device in the 510(k) summary.
| Performance Characteristic | Standard/Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (One-Fil Putty Injectable) |
|---|---|---|
| Curing Time | < 1 hour (Predicate: 53 min) | 54 min |
| pH | Not explicitly stated as a limit in the document, but predicate showed 12.79. Implies similar biocompatible pH. | 13.06 |
| Radiopacity | Not explicitly stated as a limit in the document, but predicate showed 10.81. Implies similar visibility on radiographs. | 9.20 |
| Solubility | Not explicitly stated as a limit in the document, but predicate showed 1.3%. Implies similar low solubility. | 1.1% |
| Biocompatibility | Yes (in accordance with ISO 10993-1 and ISO 7405) | Yes (in accordance with ISO 10993-1 and ISO 7405) |
| Conformance to ISO 6876 | Conformed to ISO 6876 | Conformed to ISO 6876 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual performance test (Curing Time, pH, Radiopacity, Solubility). These are bench tests conducted in a laboratory setting. The data provenance would be laboratory testing conducted by MEDICLUS Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a material testing study, not a study involving human experts establishing ground truth for diagnostic interpretations. The "ground truth" is defined by the objective measurements according to the specified international standards.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically for subjective interpretations by multiple human readers, which is not relevant for objective material performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices assessing human performance, not for dental material properties.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or AI device. The "standalone performance" refers to the device's intrinsic physical and chemical properties as measured in laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (e.g., curing time, pH, radiopacity, solubility) is established through objective laboratory measurements conducted according to the methodology outlined in ISO 6876: Dental root canal sealing materials. For biocompatibility, the ground truth is established by adherence to ISO 10993-1 and ISO 7405.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set for an AI/ML model, this question is not applicable.
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(42 days)
Korea, South
Re: K251283
Trade/Device Name: Once-Fil Flow
Regulation Number: 21 CFR 872.3690
Name:** Tooth Shade Resin Material
- Product Code: EBF
- Classification regulation: 21 CFR 872.3690
- Temporary inlay and onlay treatments of the cavity.
- Sealing of openings for implant screws.
- Relining material for temporary crowns and bridges.
- Covering of the gingival margin
- Fixing of resin matrix during filling placement.
- Block-out material for retentive ares in the dental arch, e.g. before taking impressions.
Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases.
To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration.
The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.
The provided FDA 510(k) clearance letter and summary for "Once-Fil Flow" does not describe an AI medical device or an AI/ML software. Instead, it pertains to a dental resin material. Therefore, the request to describe the acceptance criteria and study proving the device meets those criteria for an AI device cannot be fulfilled from the provided text.
The information in the provided text focuses on the material characteristics and biocompatibility of a dental flowable resin. The regulatory context described is for a Class II medical device, product code EBF (Tooth Shade Resin Material), regulated under 21 CFR 872.3690.
The document highlights the basis for substantial equivalence to a predicate device (Clip Flow by VOCO GmbH, K153493) through:
- Identical Indications for Use: Temporary inlay/onlay, sealing implant screw openings, relining temporary crowns/bridges, covering gingival margin, fixing resin matrix, and block-out material.
- Similar Technological Characteristics: Light curing type, similar materials (with minor differences confirmed by performance and biocompatibility), same intended user, similar delivery method, same period of use and shelf-life.
- Performance Testing (Non-Clinical): Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Water Sorption/Solubility, Color and Color Stability, and Shore D Hardness, all tested in accordance with ISO 4049 and ISO 868.
- Biocompatibility Testing: ISO 10993 series tests including cytotoxicity, irritation, systemic toxicity, and skin sensitization.
No information regarding AI, machine learning, clinical image analysis, or human reader studies is present in the provided text. The request for details on sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, ground truth types, and training set information is not applicable to this specific device (a dental resin material) based on the supplied documentation.
Therefore, since the input document describes a physical dental material and not an AI/ML medical device, I cannot extract the requested information regarding AI acceptance criteria and study details.
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(115 days)
405-821
SOUTH KOREA
Re: K250317
Trade/Device Name: EsFlow PLUS
Regulation Number: 21 CFR 872.3690
shade resin material |
| Classification Name | Material, Tooth Shade, Resin |
| Regulation Number | 872.3690
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.
I apologize, but the provided text from the FDA 510(k) Clearance Letter for "EsFlow PLUS" does not contain the information requested about acceptance criteria and the study proving the device meets those criteria, especially not in the context of an AI/ML medical device.
The document is for a "Tooth Shade Resin Material" (a dental composite material), which is a physical material, not an AI/ML software device. The clinical studies mentioned (depth of cure, flexural strength, compressive strength) are material performance tests, comparing the new dental resin to a legally marketed predicate dental resin, and ensuring both meet ISO standards.
Therefore, I cannot extract the following information from the provided text as it is not present for this type of device and study:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on the physical and mechanical properties of a dental composite material, comparing it to an existing material to demonstrate substantial equivalence, as required for a 510(k) clearance for this type of Class II device.
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(5 days)
Paul, Minnesota 55114
Re: K251578
Trade/Device Name: Beautifil II
Regulation Number: 21 CFR 872.3690
- Anterior and posterior restorations
- Repair of restorations and prostheses
- Core-build up
- Direct laminate veneer
Not Found
The provided text is a standard FDA 510(k) clearance letter for a dental resin material, "Beautifil II." This document confirms that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices.
*Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device. The product, "Beautifil II," is a physical dental material (tooth shade resin), not an AI/ML software device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance
- Sample sizes for test sets or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- MRMC study details or effect sizes
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size or how its ground truth was established
The 510(k) clearance process for a material like Beautifil II typically involves different types of testing (e.g., biocompatibility, physical properties, mechanical strength, chemical composition) to demonstrate safety and effectiveness, rather than a clinical study with image-based ground truth and human reader performance evaluation as would be done for an AI/ML diagnostic aid.
If you have a document describing the testing for an AI/ML device, please provide that, and I would be happy to analyze it against your request.
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(70 days)
Gresham, Oregon 97030
Re: K250778
Trade/Device Name: Sil-Flow
Regulation Number: 21 CFR 872.3690
Name of device:* Sil-Flow
Classification Name: Tooth Shade Resin Material
CFR: 21 CFR 872.3690
Sil-Flow is indicated for
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities
Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.
The provided FDA Premarket Notification (510(k)) for the Sil-Flow device is for a Tooth Shade Resin Material and NOT an AI/Software as a Medical Device (SaMD) product. Therefore, the information typically found in such a submission regarding AI device performance, such as:
- Acceptance Criteria for AI performance metrics (e.g., sensitivity, specificity, AUC)
- Study design for AI performance evaluation (e.g., standalone, human-in-the-loop, MRMC)
- Sample size and data provenance for AI test sets
- Ground truth establishment (number/qualifications of experts, adjudication methods)
- Training set details for AI models
- Effect size of AI assistance for human readers
are not present in this document.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Clip Flow) based on physical and chemical properties, biocompatibility, and intended use for a dental material.
Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent from the perspective of an AI/SaMD device:
Acceptance Criteria and Study Proving Device Meets Criteria (for Dental Material)
The acceptance criteria and supporting study for Sil-Flow relate to its physical, chemical, and biological properties as a tooth shade resin material, demonstrating its safety and performance for its indicated uses.
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria (from ISO 4049 Protocol) | Reported Device Performance | Comments |
|---|---|---|---|
| Physical/Chemical Properties | |||
| Visual Appearance | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Depth of Cure (mm) | Not explicitly stated (but referenced ISO 4049) | 3.1 mm | Predicate device (Clip Flow) reported 11mm, suggesting a difference. However, "Both the subject devices and the predicate device have physical parameters which meet the requirements of the relevant ISO standards," implying 3.1mm is acceptable per the standard for Sil-Flow. |
| Shor Hardness D | Not explicitly stated | 52 Shor D | Predicate (Clip Flow) reported 90 Shore A. Note the difference in Shore scale (D vs. A), making direct comparison difficult without a conversion or further context, but still stated to meet relevant ISO standard. |
| Sensitivity to Ambient Light | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Water Sorption (µg/mm³) | <40 µg/mm³ (from predicate) | <40 µg/mm³ | Explicitly stated and met. |
| Water Solubility (µg/mm³) | <7.5 µg/mm³ (from predicate) | <7.5 µg/mm³ | Explicitly stated and met. |
| Color Stability | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Shade Stability | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Biocompatibility Testing | |||
| Cytotoxicity | Pass (according to ISO 10993-05) | Passed | Explicitly stated. |
| Irritation | Pass (according to ISO 10993-10) | Passed | Explicitly stated. |
| Sensitization | Pass (according to ISO 10993-10) | Passed | Explicitly stated. |
| Acute Systemic Toxicity | Pass (according to ISO 10993-11) | Passed | Explicitly stated. |
| Stability (Shelf Life) | |||
| Shelf Life | Demonstrated at 3 years | 3 years | "All shelf life determinations use the same testing protocols as the characterization testing which are based on ISO 4049." |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The testing summary refers to "protocols based on ISO 4049," which would define the number of samples for each test (e.g., number of specimens for depth of cure, water sorption, etc.), but the exact numbers are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing is in vitro (laboratory testing of the material itself) and biocompatibility testing on biological models, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a dental material, "ground truth" is established through standardized laboratory measurements and validated biological tests, not human expert interpretation of clinical images or data in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. This concept applies to human-reviewed clinical data, not material property testing.
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/SaMD device. No MRMC study was performed as it's typically for assessing the impact of AI on diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/SaMD device. "Standalone performance" refers to an AI algorithm's performance without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Laboratory Standard Measurements and Biocompatibility Test Results: The "ground truth" for this device is derived from the results of standardized physical property tests (e.g., specific gravity measurements for water sorption, calibrated hardness testers for Shor hardness, optical measurements for depth of cure) and the results of validated biocompatibility assays following ISO 10993 standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/SaMD device. There is no "training set" in the context of an AI model for this dental material. The material itself is manufactured and tested.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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(29 days)
27472
GERMANY
Re: K251239
Trade/Device Name: GrandioSO Unlimited
Regulation Number: 21 CFR 872.3690
- class I to V restorations
- reconstruction of traumatically damaged anteriors
- facetting of discolored anteriors
- correction of shape and shade for improved aesthetic appearance
- locking, splinting of loose teeth
- repairing veneers
- restoration of deciduous teeth
- core-build-up under crowns
- composite inlays
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The provided FDA 510(k) Clearance Letter for "GrandioSO Unlimited" indicates that the device has been cleared as a "Tooth Shade Resin Material" (Product Code: EBF). This means it is a dental filling material, and the information provided in the document pertains to its substantial equivalence to predicate devices, its intended uses, and regulatory compliance.
Crucially, this document is a regulatory clearance for a physical dental material, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/SaMD performance (e.g., accuracy, sensitivity, specificity for diagnostic or assistive AI) are not applicable to this specific dental material clearance letter.
The clearance for a dental material like GrandioSO Unlimited is based on demonstrating substantial equivalence to a legally marketed predicate device, typically through:
- Material properties testing: Demonstrating that the physical, chemical, and mechanical properties (e.g., flexural strength, wear resistance, color stability, biocompatibility) are comparable to the predicate device.
- Biocompatibility testing: Ensuring the material is safe for use in the body.
- Clinical use claims: Showing that the material can be used for the stated indications (e.g., Class I to V restorations) effectively and safely, often supported by existing literature or non-clinical data if the material formulation is similar to established products.
Therefore, I cannot extract the requested information (1-9) from the provided text because these elements are specific to the validation of AI/SaMD performance, not the regulatory clearance of a dental restorative material.
The document states:
- Device Name: GrandioSO Unlimited
- Regulation Name: Tooth Shade Resin Material
- Product Code: EBF
- Indications for Use: Class I to V restorations, reconstruction of traumatically damaged anteriors, facetting of discolored anteriors, correction of shape and shade for improved aesthetic appearance, locking, splinting of loose teeth, repairing veneers, restoration of deciduous teeth, core-build-up under crowns, composite inlays.
These are typical uses for a dental composite material. The "study" proving it meets "acceptance criteria" would be a battery of standard dental material tests and biocompatibility assessments, demonstrating its equivalence to existing, legally marketed tooth shade resin materials. This letter does not contain the specifics of those material tests or any AI/SaMD-related performance metrics.
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