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Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration

Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength. Various shades of TW, A1, A2, A3, B1, C2, AO3 and BL for esthetic crown are provided. Hexa-Temp contains about 38% inorganic filler. Inorganic filler has a size of 16nm ~ 3.22µm.

This document is a 510(k) Premarket Notification from the FDA for a dental product called "Hexa-Temp." It is not a document describing an AI device or a study validating AI performance. Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets those criteria, as the document does not contain this information for an AI/algorithm-based device.

The document discusses the substantial equivalence of the "Hexa-Temp" temporary crown and bridge resin to a predicate device, "Structur 2 SC," based on bench performance testing and biocompatibility.

Here's a breakdown of what the document does provide:

• Device: Hexa-Temp (Temporary Crown and Bridge Resin)
• Manufacturer: SPIDENT Co., Ltd.
• Predicate Device: STRUCTUR 2 SC, VOCO GMBH, K040769
• Purpose: To demonstrate substantial equivalence to a legally marketed predicate device.
• Testing methods: Bench performance testing (conforming to ISO 10477:2018) and Biocompatibility testing (conforming to various ISO 10993 standards and ISO 7405:2018).
• Key performance parameters evaluated (acceptance criteria are implicit in meeting ISO standards and showing comparable/superior performance to predicate):
  • Water sorption
  • Solubility
  • Color and color consistency/stability
  • Polymerization Temperature
  • Polymerization Shrinkage
  • Compressive Strength
  • Flexural Strength
  • Surface finish
• Comparison provided in a table: A direct comparison of Hexa-Temp to Structur 2 SC for various characteristics including chemical composition, indications for use, principle of operation, mechanical properties, and biocompatibility.

Therefore, it is impossible to extract the specific information requested in your prompt (about AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) from this physical device submission.

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