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Statement of the intended use

ALLOY PRIMER is indicated for the following applications:

1. Adhesion of metal posts, metal inlays, onlays, crown and bridges

2. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns

3. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

ALLOY PRIMER is an adhesion primer between dental metal alloy and resin-based material for dental practitioner or dental technician, and comprises methacrylate monomers and solvent. It is used a kind of bonding agent between metal and/or tooth substrate using resin-based materials for the intended uses.

The provided document is a 510(k) summary for the device ALLOY PRIMER by Kuraray Medical Inc. It primarily focuses on changing the manufacturer's name and address and states that the device is "essentially the same" as a previously cleared predicate device (K974089).

Therefore, the document does not contain information about new acceptance criteria or a study proving the device meets new acceptance criteria. It refers to the predicate device having already satisfied these requirements.

Based on the provided text, I cannot fill in the requested table and study details because the submission is for an administrative change and not for a new device requiring a new performance study.

However, I can extract information related to what typically would be expected if such a study were present:

Missing Information:

• Acceptance Criteria and Reported Device Performance: This document does not establish new acceptance criteria or report new device performance data. It relies on the predicate device's performance.
• Sample size used for the test set and the data provenance: Not applicable, as no new test set was used for a new study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does state:

• Device Name: ALLOY PRIMER
• Predicate Device: ALLOY PRIMER by Kuraray Co., Ltd. (K974089)
• Reason for 510(k) submission: "to alter the name and address of manufacturer, and not to intend other changes."
• Technological Characteristics and Safety: "This device is essentially the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as ALLOY PRIMER (K974089)."
• Intended Use: "The intended uses of this device are... completely the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. (K974089)."
  1. Adhesion of metal posts, metal inlays, onlays, crown and bridges
  2. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
  3. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures.
• Classification Name: Resin tooth bonding agent (21CFR 872.3200)
• Regulatory Class: II
• Product Code: KLE

Conclusion:

This 510(k) submission is for a change in manufacturer information, asserting substantial equivalence to a previously cleared device. It does not present new acceptance criteria or a study demonstrating the device meets such criteria because it claims the device is identical in all relevant aspects to its predicate. Therefore, the detailed information about studies and acceptance criteria is inherent to the predicate device's clearance (K974089) and not present in this document.

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PANAVIA F is indicated for the following applications:
Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays.
Cementation of to composite resin crowns, inlays and onlays
Cementation of adhesion bridges and splints
Cementation of metal cores and prefabrication posts
Bonded amalgam restorations

PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crowns or bridges.
PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089).
This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories.

This is a 510(k) premarket notification for a dental adhesive device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics is not available in the provided text.

The document discusses the substantial equivalence of the "PANAVIA F" dental cement to predicate devices already on the market. The "acceptance criteria" in this context refer to the regulatory requirements for showing the new device is as safe and effective as existing ones, rather than performance metrics for an AI algorithm.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document states "These modifications do not affect the safety and effectiveness" of PANAVIA F compared to PANAVIA 21. The "performance" is implicitly tied to its intended use for cementation of dental devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a medical device's components and intended use, not a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

The core argument for the device's acceptance is its "substantial equivalence" to legally marketed predicate devices, meaning it shares similar design, composition, function, and intended use, and that any modifications do not negatively impact its safety and effectiveness.

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