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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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