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HySil Heavy Plus is to be used as heavy-bodied materials for:

• One-step impression technique (simultaneous technique) using single or dual viscosities -
• Two-step impression technique using dual viscosities -
• Functional impressions -

HySil Mono Plus is to be used as a medium-bodied tray or syringeable impression material for:

• Taking impressions over fixed/removable restorations and implants -(i.e., transferring impressi on posts and bridge components)
• Functional impressions -
• Fabricating crown and bridgework or inlays -
• -Fabricating full or partial dentures
• Reline impressions -
• -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
• -Transferring root posts when fabricating posts and cores indirectly

HySil Light Plus is to be used as syringeable impression materials for:

• Two-step putty-wash impression technique -
• One-step putty-wash impression technique -
• Two-step impression technique using dual viscosities -
• Reline impressions -
• Fabricating full or partial dentures -

HySil Heavy Plus Auto is to be used as heavy-bodied materials for:

• One-step impression technique (simultaneous technique) using single or dual viscosities -
• Two-step impression technique using dual viscosities -
• Functional impressions -

HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.

I am sorry, but the provided text does not contain information about a study proving a device meets acceptance criteria related to artificial intelligence (AI) performance in medical image analysis. The document is an FDA 510(k) premarket notification for "HySil Plus Impression Materials," which are dental impression materials.

The document discusses:

• The device's name, regulation number, classification, and product code.
• Indications for use for different viscosities of the impression materials.
• Comparison to predicate devices, focusing on material composition, standards conformed to (ISO 4823), working time, shelf-life, and principle of operation.
• Non-clinical performance testing, including biocompatibility (ISO 10993-1, 5, 10, 11), sterilization validation (not applicable as non-sterile), shelf-life determination, and mechanical properties (ISO 4823).
• A statement that "No clinical studies are submitted."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI-powered device meets them, as this document is about a dental impression material and does not involve AI or medical image analysis.

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