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Found 6 results
510(k) Data Aggregation
(55 days)
The JETPOLISHER airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets
Not Found
I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device called "JetPolisher." It primarily concerns the regulatory approval process and does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory compliance requirements.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as they are not present in the provided text.
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(55 days)
The JETSTREAM airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
JETSTREAM airpolishing unit
This document is a 510(k) clearance letter from the FDA for a dental device called "JetStream". It does not contain information regarding an acceptance criteria study or performance data, sample sizes, expert qualifications, or ground truth establishment for an AI or imaging device. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot provide the requested information based on the input document. The document is not related to the type of study described in the prompt.
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(34 days)
The JETSONIC 2000 combines both scaling and airpolishing functions in one The 62100110 2000 wers all prophylaxis needs. The airpolishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler michaed to be used to be used for for fast and reliable removal of light to heavy calculus and plaque. Carculus and plaque. Device applications: Routine oral prophylaxis , routine polishing especially hard to Device applications. It enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
The JETSONIC 2000 combines both scaling and airpolishing functions in one
Based on the provided text, the document is a 510(k) clearance letter for a dental device, the "JetSonic 2000." This letter indicates that the device has been found substantially equivalent to a predicate device, which allows it to be marketed.
However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).
The text describes the device's indications for use:
- Airpolishing function: intended to remove stubborn stains, plaque, and soft debris.
- Scaler function: intended for fast and reliable removal of light to heavy calculus and plaque.
- Device applications: Routine oral prophylaxis, routine polishing especially hard to clean areas, enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets.
Since the device received 510(k) clearance based on substantial equivalence, the "study" that proves it meets acceptance criteria is primarily a comparison to a legally marketed predicate device, demonstrating that it has similar technological characteristics and is as safe and effective. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
Therefore, I cannot fill out the requested table or answer the specific questions about studies, sample sizes, ground truth, experts, or comparative effectiveness, as this information is not present in the provided document.
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(29 days)
The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system
removal of light to h removal or light to tight to time for each scaling insert.
Not Found
This document is a 510(k) clearance letter from the FDA for the Delsonic 2000 Ultrasonic Scaler. It confirms that the device is substantially equivalent to a legally marketed predicate device.
It does NOT contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The content is primarily administrative, confirming FDA clearance and outlining general regulatory requirements.
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(38 days)
Miniblaster is an autoclavable clinical sandblaster for:
- Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
- Sandblasting to remove residual cement from crowns and bridged. .
- Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs.
- Sandblasting of orthodontic bands removes cement and enhances bonding. ●
- Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ●
- Sandblasting of all surfaces to be bonded. .
Miniblaster is an autoclavable clinical sandblaster
This document is a 510(k) clearance letter from the FDA for a dental device called "MiniBlaster Clinical Sandblaster." It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These details are typically found in the 510(k) submission summary or other supporting documentation, which is not present here.
Therefore, I cannot provide the requested table and study details based on the input text. The input only indicates the FDA's clearance of the device based on substantial equivalence, and lists its intended uses.
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(49 days)
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