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The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.

hand held ultrasonic instruments

The provided document is an FDA 510(k) clearance letter for the "Dream Cleans 'S' Scaler and Compact 'S' Scaler." This type of document does not contain information about acceptance criteria or detailed study results for device performance.

The 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. It relies on a comparison of technological characteristics and indications for use.

Therefore, I cannot extract the requested information from this document. To answer your questions, one would typically need access to the 510(k) submission itself or a separate study report.

Here's why the document doesn't contain the requested information:

• Acceptance Criteria & Device Performance: The letter states that the device is "substantially equivalent" to a predicate device. It doesn't detail performance metrics or acceptance criteria for those metrics.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all elements of a detailed study design and results, which are not typically included in the final FDA clearance letter. The letter confirms a regulatory decision, not the scientific details of the submission's evidence.

In summary, based solely on the provided text, I cannot provide the requested details regarding acceptance criteria and the study that proves the device meets them because this information is not present in the FDA 510(k) clearance letter.

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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.

Ask a specific question about this device