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Direct restoration of Class I-V cavities (according to G.V. Black) Direct composite veneers Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) Splinting of teeth loosened by trauma or periodontal disease Restoration of primary teeth Repairs of porcelain, composite (in combination with an adequate repair-system)

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I am sorry, but the provided text from the FDA 510(k) approval letter for "Charisma" a "Tooth Shade Resin Material" does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance data, clinical study designs, or technical acceptance criteria for the device itself.

The document primarily covers:

• The FDA's review and determination of substantial equivalence.
• Regulatory information and requirements for marketing the device.
• Contact information for FDA divisions.
• The indications for use for the "Charisma" device, listed as:
  • Direct restoration of Class I-V cavities (according to G.V. Black)
  • Direct composite veneers
  • Shape corrections of teeth (i.e., diastemas, congenital defects in teeth, etc.)
  • Splinting of teeth loosened by trauma or periodontal disease
  • Restoration of primary teeth
  • Repairs of porcelain, composite (in combination with an adequate repair-system)

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details based on the given text.

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The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or selfcuring core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations.

The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for K150933, regarding the iBond Universal and iBond Ceramic Primer, does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include the technical study details typically found in a clinical study report or a more comprehensive 510(k) submission summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions about the study design and results based on the provided text.

Ask a specific question about this device