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K Number
K221033
Device Name
UniPrime A, UniPrime E, UniPrime E/C
Manufacturer
S&C Polymer Silicon- und Composite Spezialitäten GmbH
Date Cleared
2022-07-06

(90 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K150703
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

UniPrime A is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia and metal/alloy.

UniPrime E is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of zirconia, composite and metal/alloy.

UniPrime E/C is a MDP containing universal primer 1) for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges and 2) for the intraoral repair of fractured restorations made of ceramic, zirconia, composite and metal/alloy.

Device Description

UniPrime A is a MDP containing universal primer for the bonding of methacrylate based dental materials to zirconia and metal/alloy frameworks, crowns and bridges (indications from labeling).

UniPrime E is a MDP containing universal primer for the bonding of methacrylate based. dental materials to zirconia, composite and metallalloy frameworks, crowns and bridges (indications from labeling).

UniPrime E/C is a MDP containing universal primer for the bonding of methacrylate based dental materials to ceramic, zirconia, composite and metal/alloy frameworks, crowns and bridges (indications from labeling).

AI/ML Overview

This looks like a 510(k) submission for dental primers, not a software device or an AI/ML product. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI/ML specific aspects (like MRMC studies) is not applicable to this document.

The document discusses the substantial equivalence of the UniPrime series of dental primers to a predicate device based on:

  • Device description: MDP containing universal primer for bonding methacrylate-based dental materials.
  • Intended use: Improves bonding of methacrylate-based dental materials to various surfaces (zirconia, metal/alloy, ceramic, composite).
  • Indications for use: Specifically lists bonding and intraoral repair for different material combinations (detailed for UniPrime A, E, and E/C).
  • Mechanism of action: Equal to the predicate.
  • Form of delivery: Bottle.
  • Ingredients: Solvent, MDP, Silane.
  • Performance Evaluation: The document states, "The subject device has been evaluated for adhesive strength to indicated surfaces, pH, and biocompatibility." However, it does not provide the specific acceptance criteria for these evaluations nor the detailed results of the studies.

In summary, this document does not contain the type of AI/ML-related performance data and study details you are asking for. It is a regulatory submission for a physical dental product, demonstrating substantial equivalence to a previously cleared device.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.