(240 days)
G-Cem LinkForce
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- Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
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- Cementation of metal, ceramic, fiber posts, and cast post and cores.
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- Cementation of all ceramic and composite veneers (up to 2 teeth)
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- Permanent cementation of crowns and bridges on implant abutments.
GC DUAL CURE ACTIVATOR
- Cementation of indirect restorations.
- Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
- Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.
TRY-IN PASTE
To evaluate the shade and the fitting of the restoration prior to permanent cementation.
MULTI PRIMER
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- Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
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- Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.
G-CEM LinkForce is a dual-cured resin cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. G-CEM LinkForce is available in 4 shades: Translucent, A2, Opaque, Bleach.
GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used with G-Premio BOND (510(k) No. K143140).
TRY-IN PASTE is a hue-conformity verification material. The product is placed into a dental restoration and set on an abutment tooth to verify hue and conformity. The product has a same color as G-CEM LinkForce.
MULTI PRIMER is a priming agent designed to treat the adherend surface of glass ceramic, oxide ceramic, hybrid ceramic, composite and metal restorations to promote a strong bond to resin-based materials as resin-based cements in case of luting procedures or direct composites in case of repairs.
Here's a breakdown of the acceptance criteria and the study information for the G-Cem LinkForce, GC Dual Cure Activator, Try-In Paste, and Multi Primer devices, based on the provided text.
Note: The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone clinical study for the new device. Therefore, much of the requested information regarding detailed clinical study design (sample size, ground truth, experts, MRMC studies, training set details) is not present. The studies mentioned are primarily in vitro performance bench tests against ISO standards.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by ISO standards and internal company specifications. The document states that the applicant device conforms to these required specifications.
Table of Acceptance Criteria and Reported Device Performance (Summary from Tables 5.2, 5.3, 5.4, 5.5)
| Device Group | Property | Standard / Test Method | Acceptance Criteria (Requirements) | Reported Device Performance (Implied) |
|---|---|---|---|---|
| G-CEM LinkForce | Film thickness | ISO 4049: 2009 5.2.2 | No greater than 50 µm | Meets criteria (implied) |
| Working time | ISO 4049: 2009 5.2.4 | No detectable change in its homogeneity | Meets criteria (implied) | |
| Setting time | ISO 4049: 2009 5.2.6 | Not more than 10 min | Meets criteria (implied) | |
| Depth of cure (Opaque shade) | ISO 4049: 2009 5.2.8 | Not less than 0.5 mm | Meets criteria (implied) | |
| Depth of cure (Other shade) | ISO 4049: 2009 5.2.8 | Not less than 1.5 mm | Meets criteria (implied) | |
| Flexural strength | ISO 4049: 2009 5.2.9 | Greater than 50 MPa | Meets criteria (implied) | |
| Water sorption | ISO 4049: 2009 5.2.10 | Less than 40 µg/mm | Meets criteria (implied) | |
| Solubility | ISO 4049: 2009 5.2.10 | Less than 7.5 µg/mm | Meets criteria (implied) | |
| Radiopacity | ISO 4049: 2009 5.5 | Greater than the same thickness of aluminum | Meets criteria (implied) | |
| GC DUAL CURE ACTIVATOR (with G-Premio BOND) | Adhesion to Bovine Dentin | ISO 11405: 2015 5.1.4 (Shear bond strength) | Greater than 5MPa | Meets criteria (implied) |
| Adhesion to Bovine Enamel | ISO 11405: 2015 5.1.4 (Shear bond strength) | Greater than 9MPa | Meets criteria (implied) | |
| TRY-IN PASTE | Film thickness | Company Specification | No greater than 50 µm | Meets criteria (implied) |
| MULTI PRIMER | Tensile bond strength to Porcelain | Company Specification | Greater than 10MPa | Meets criteria (implied) |
| Tensile bond strength to Zirconia | Company Specification | Greater than 10MPa | Meets criteria (implied) | |
| Tensile bond strength to Au-Ag-Pd alloy | Company Specification | Greater than 10MPa | Meets criteria (implied) |
Biocompatibility for all devices (G-CEM LinkForce, GC DUAL CURE ACTIVATOR, TRY-IN PASTE, MULTI PRIMER):
- Cytotoxicity (ISO 10993-5): No cytotoxic effect.
- Sensitization (ISO 10993-10): 0% sensitization rate, non-irritant to buccal tissues.
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance bench tests according to ISO standards, not a clinical test set with human subjects.
- Sample Size: Not explicitly stated for each specific test, but ISO standards typically involve a defined number of specimens for mechanical and physical property testing.
- Data Provenance: In-vitro laboratory testing, likely conducted by the manufacturer, GC America Inc. Country of origin not specified, but the submission is to the US FDA. The data is retrospective in the sense that it's reported on already conducted tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for performance bench tests is the objective measurement of physical and mechanical properties against pre-defined engineering and material standards (ISO standards, company specifications). There's no "expert ground truth consensus" involved in this type of testing.
4. Adjudication Method for the Test Set
Not applicable. This type of performance testing involves direct physical measurements, not interpretation or adjudication by experts.
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 submission is for dental cements and primers, which are materials, not AI-powered diagnostic or assistive devices that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. These are physical dental materials, not algorithms.
7. The Type of Ground Truth Used
The ground truth used for these performance bench tests are:
- Established ISO standards for dental materials (ISO 4049:2009, ISO 11405:2015, ISO 10993-5, ISO 10993-10). These standards define the methodology and acceptable ranges for various physical, mechanical, and biological properties.
- Company Specifications for properties like film thickness (Try-in Paste) and tensile bond strength to various restorative materials (Multi Primer).
8. The Sample Size for the Training Set
Not applicable. These are dental materials tested against standards, not AI algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.