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• Bonding of indirect restorations made of composite, all-ceramic and metal.
• Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments.
• Dental core bonding.

The subject device is a dual-cure resin cement for dental adhesion composed of two types of paste: the Catalyst Paste and the Base Paste. Each paste is filled separately in the independent double-barrel syringe and is mixed and dispensed through a dedicated mixing tip attached to the syringe nozzle. To match the color of the prepared tooth structure (dentin and enamel) and the prosthetic restoration, the Base Paste is available in four shades: Translucent, Yellow, White, and Opaque. The accessory tips include iCEM Universal Plus Mixing Tips and iCEM Universal Plus Endo Tips (consisting of Endo Mixing Tips and Extension Tips), which differ in tip diameter and are selected according to the clinical indication. All tips are single-use only. The mixed resin cement cures through both chemical and light polymerization. The subject device can adhere to tooth structure (dentin and enamel) using iCEM Universal Plus Cement, with or without the use of iCEM Universal Plus Primer, depending on the clinical indication:
• Self-Adhesive Mode: Using only iCEM Universal Plus Cement as a self-adhesive resin cement.
• Adhesive Mode: Using iCEM Universal Plus Cement in combination with the dedicated primer, iCEM Universal Plus Primer, as an adhesive resin cement.
When used in the adhesive mode, iCEM Universal Plus Primer contains a portion of the polymerization initiators involved in the chemical polymerization of the subject device. Upon contact with the subject device, these initiators are activated, initiating the polymerization of the monomers and resulting in curing. This combination enhances the bond strength to tooth structure (dentin and enamel) compared to the Self-Adhesive Mode.

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• Cementation of all-ceramic, composite, and metal crowns, bridges, inlays, onlays, dental posts; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (contraindicated for patients with bruxism or periodontitis).
• Cementation of fiber posts.
• Cementation of all-ceramic, composite, and metal restorations on implant abutments.

TopCEM Vigor SA Self-Adhesive Resin Cement is a dual-curing (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The cement contains inorganic fillers, and the inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. The mixing ratio, based on volume, is 1 part base paste: 1 part catalyst paste. TopCEM Vigor SA Self-Adhesive Resin Cement is delivered in double-barrel syringes. TopCEM Vigor SA Self-Adhesive Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

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• Restorations of deciduous teeth
• Non-load bearing Class I and Class II restorations in permanent teeth
• Restorations of Class V cavities and wedge-shaped defects

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• Class I and II restorations in deciduous teeth
• Class I, and non-stress bearing Class II restorations in permanent teeth
• Stress bearing Class II restorations in permanent teeth, keeping ≥1 mm distance from the cusp tips

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1. Class I, II, III, IV and V restorations
2. Root surface restoration
3. 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.

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Rodin Envision veneer cement (Light Cure):

• Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
• Only use Rodin Envision veneer cement Light Cure for restorations with a low thickness of <2mm that have sufficient translucency.

Rodin Luting Cement (Dual Cure):

• Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
• Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

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Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
2. Endodontic posts
3. Cement-retained implant restorations/abutments (i.e. screws and crowns)
4. Veneers

Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.

The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:

"Clinical testing is Not Applicable."

Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.

Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.

However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:

Non-Clinical Performance Study Details for Choice 2 DC Dental Cement

The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.

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

• Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
• Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.

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

• Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical material testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. This applies to diagnostic devices, not dental cements.

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

• Not applicable. This applies to diagnostic algorithms, not dental cements.

7. The Type of Ground Truth Used

• The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.

8. The Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device or a clinical study requiring training data.

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

• Not applicable, as there is no training set mentioned or implied.

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Final cementation of

• Metal inlays, onlays, crowns and bridges
• Resin inlays, onlays, crowns and bridges
• Ceramic inlays
• Zirconia crowns and bridges
• Metal, ceramic and fiber posts

EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.

This is a 510(k) premarket notification for a dental cement, EsCem RMGI. The provided document does not contain any information about an AI/ML powered device or a study involving human readers or AI assistance. It focuses solely on the substantial equivalence of the dental cement to a predicate device based on its physical and chemical properties and biocompatibility.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
• Information about MRMC studies, effect sizes of AI assistance, or standalone AI performance.
• Details about ground truth for training sets or their establishment for AI/ML.

The document discusses the following performance criteria for the dental cement:

1. Acceptance Criteria and Reported Device Performance (for the dental cement, not an AI device):

The document states that the flexural strength and film thickness tests of EsCem RMGI were conducted in accordance with ISO 9917-2. It also mentions that the technical data sheet of the predicate device (RelyX™ Luting Plus Automix) was referenced for these mechanical properties.

The report's conclusion is: "The flexural strength and film thickness test results of the subject device and predicate device meet the ISO 9917-2 requirements, and the values of those performances are comparable to those of the predicate device."

Without the actual numerical values from the "technical data sheet" or the "test results" for EsCem RMGI, a specific table cannot be created. The document only confirms compliance with the ISO standard and comparability.

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

The document does not specify sample sizes for the flexural strength and film thickness tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that biocompatibility testing was performed in accordance with ISO 10993-1.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring expert consensus for image interpretation or diagnosis.

4. Adjudication Method:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring adjudication of expert readings.

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

This information is not applicable as the clearance is for a dental cement, not an AI device that assists human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the clearance is for a dental cement, not an AI algorithm.

7. Type of Ground Truth Used:

For the dental cement's performance:

• Flexural Strength and Film Thickness: The "ground truth" or reference for performance is established by the ISO 9917-2 standard and comparison to the predicate device's technical data sheet. These are objective, measurable physical properties.
• Biocompatibility: Established by adherence to ISO 10993-1 and specific tests (in vitro cytotoxicity, skin sensitization, irritation testing).

8. Sample Size for the Training Set:

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

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

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

In summary, the provided FDA 510(k) clearance letter pertains to a dental cement and does not describe an AI/ML-powered device. Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth establishment is not present in this document.

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