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"DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

"DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.

"DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

"DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.

"DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

General:- Dental Alloys
Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Dream Bond, DreamCast V, DreamCast Chrome, Dream FlexiCast, and Dream LitheCast devices.

The document is a 510(k) premarket notification letter from the FDA to American Green Dental Manufacturing, Inc. It states that the referenced devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the new devices are as safe and effective as existing ones, but it does not detail specific acceptance criteria or performance studies of the devices themselves within this document.

The document focuses on:

• FDA's determination of substantial equivalence (K033045).
• Regulation numbers and product codes for the devices.
• General controls and additional controls that may apply.
• Contact information for various FDA offices.
• Indications for Use for each device.
• Classification as Prescription Use.

Therefore, I cannot provide the requested information based on the text provided.

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Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances.

Flexicast Prime ( Partial Denture Dental Casting Alloy )

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental casting alloy named "Flexicast Prime."

It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Information on MRMC studies or standalone algorithm performance.

The letter explicitly states that it is a response to the premarket notification submission and that "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market." This type of document typically does not elaborate on the specific performance studies that were submitted to demonstrate substantial equivalence, but rather notifies the applicant of the FDA's decision.

Ask a specific question about this device

Ask a specific question about this device