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The Century 105C Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

The Century 105C Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by pneumatic pressure on a rotor with roller bearings. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

This document provides a 510(k) summary for the KaVo Century 105C handpiece. This is a premarket notification for a dental device, not a study evaluating acceptance criteria of a device through clinical trials or performance testing with specific metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this document.

The document discusses:

• Device Name: KaVo Century 105C
• Intended Use: Removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces.
• Substantial Equivalence: Claimed substantial equivalence to the Kaltenbach & Voigt GmbH, SUPERtorque Air-Driven Highspeed Handpieces (K073478). This means the manufacturer believes the new device is as safe and effective as a legally marketed predicate device.
• Regulatory Clearance (FDA): The FDA reviewed the 510(k) and determined the device is substantially equivalent to a predicate device, allowing it to be marketed.

This 510(k) summary is a regulatory filing, not a performance study report.

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The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.

The SONICFill 2010 is an air driven dental delivery system intended to dispense Metamorphosis, a dental restorative resin, directly into dental cavities. The device allows fast and easy extrusion of the composite, which is held in single-dose cartridges (tips). The tips are connected to the device via a screw thread. The device is attached to the dental unit through a coupling and a hose. It is powered via compressed air supplied by the operative unit. The device is switched on and off through the footswitch of the dental unit and the power output can be adjusted through a regulating ring located on the device. The devices can be sterilized by the steam autoclave method.

This document is a 510(k) summary for a dental delivery system, SONICfill 2010. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data for the SONICfill 2010 device itself.

Therefore, the requested information about acceptance criteria, device performance, study details, and ground truth cannot be extracted from the provided text for the SONICfill 2010 device. The document primarily identifies the device, its intended use, and claims substantial equivalence to another legally marketed device (Produits Dentaires Pierre Rolland, Expasyl Power Applicator (K051933)).

No studies or performance data specific to the SONICfill 2010 demonstrating it meets acceptance criteria are presented in this 510(k) summary.

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The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers intended for use in following areas:

• · Tooth scaling and cleaning · Scaling:
  • · Tooth neck and subgingival treatment
  • · Root planning
  • · Initial therapy
  • · Implant maintenance
  • · Canal preparation and cleaning
  • · Micro retro surgery
  • · Inlay / onlay condensation
  • · Fissure cleaning
  • · Minimal invasive cavity cleaning
• · Endodonties:
  · Periodontics:
• · Prosthesis:

The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers for use by qualified dental practitioners in the four conventional dental applications of scaling, periodontics, endodontics and prosthesis.

The SONICHex 2003 / SONICJlex Lux 2003 L. & Instrument Tips consist of a handpiece, instrument tips, quick-action coupling and accessories for changing and cleaning the instrument tips. The handpieces are attached over a coupling and a hose to a dental operative unit. The power delivered to the handpiece is adjusted via a control ring located on the handpiece. The only difference between the SONICflex 2003 and the SONICJlex Lux 2003 L scaler is that the SONICflex Lux 2003 1. has an integrated fiber optic. A variety of tips are available for specific dental applications and for reaching different areas of the mouth. The devices can be sterilized by the steam autoclave method.

The provided text is a 510(k) summary for a dental ultrasonic scaler, the SONICflex 2003 and SONICflex Lux 2003 L. This type of regulatory submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as one might find for a novel, high-risk device or an AI/ML-enabled device.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Here's why and what the document does indicate:

• Substantial Equivalence: The core of this 510(k) is to show that the new device (SONICflex 2003 series) is "substantially equivalent in design, application and function" to a legally marketed predicate device (Sirona Dental Systems GmbH, SIROAIR L Air Scaler). This means the focus is on comparing features and intended use, not on generating new performance data to meet specific, predefined acceptance criteria.
• Lack of Performance Data: The document does not report any specific performance metrics (e.g., accuracy, sensitivity, specificity, or objective measurements related to scaling effectiveness) for the SONICflex 2003 series. It describes the device and its intended use but does not present data from studies designed to quantify its performance.
• Absence of AI/ML Context: This device, an ultrasonic scaler, is a mechanical dental tool. The document does not indicate any AI or machine learning components. Therefore, questions related to AI/ML specific studies (MRMC, standalone algorithm performance, AI assistance effect size) are not applicable.

In summary, based on the provided text, I cannot complete the requested tables and information because the document focuses on demonstrating substantial equivalence of a physical dental tool, not on reporting performance data from studies against specific acceptance criteria.

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The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices can be sterilized by the steam autoclave method.

The GENTLEpower Handpieces and Attachments are dental instruments for use by a trained professional in general dentistry. The handpieces and attachments are powered by either an air-motor or electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The provided text is a 510(k) Summary for dental handpieces. It describes the devices, their intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The document discusses:

• Device Names: SUPERtorque High-Speed Handpieces and GENTLEpower Handpieces and Attachments
• Common Name: Dental Handpiece
• Classification Name: Handpiece, Air-Powered, Dental
• Intended Use: Removal of carious material, reducing hard tooth structure, cavity/crown preparation, finishing tooth preparations, restorations, and polishing teeth.
• Predicate Devices: Siemens AG (now Sirona) T1 Control High-Speed Dental Handpieces (K965238), DEN-TAL-EZ, Inc. STAR DENTAL 430 Series High-Speed Handpieces (K960719), and A-DEC/W&H Synea Air-Driven Highspeed Handpieces and Attachments (K070663).
• Regulatory information: Product codes, regulation number, and classification.

To answer your request, a document detailing performance testing, clinical studies, or engineering studies would be required. The given text is purely for regulatory submission and substantial equivalence claims, not for scientific performance validation.

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The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.

The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.

The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.

The provided text is a 510(k) summary for the FixaFloss device, a waxed dental floss with a silicone conical clamping element intended for rubber dam fixation. However, it does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device (The Hygenic Corp., Wedjets). It describes the device, its intended use, and claims substantial equivalence, but it does not present:

• A table of acceptance criteria.
• Reported device performance against specific criteria.
• Details of any study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth).
• Information on training sets.

Therefore, I cannot fulfill your request based on the provided text. The document's purpose is to clear the device for market by showing it is similar to an existing product, not to publish detailed performance study results against specific criteria.

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KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.

This looks like a 510(k) premarket notification for a dental handpiece lubricant/cleaner device. The provided text does not contain any information regarding acceptance criteria, study design, or performance metrics for the KaVo QUATTROcare Modified device. It primarily focuses on the device's description, intended use, and claim of substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.

If you have a different document that details the performance study for K071288, please provide it, and I would be happy to analyze it for the requested information.

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The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.
The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.
The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.

The provided document K070327 is a 510(k) premarket notification for several intraoral devices intended for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA). A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies or acceptance criteria with specific metrics from clinical trials, especially when not a novel device requiring such studies.

Based on the information provided, there is no specific study described that outlines acceptance criteria in terms of quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) and then proves the device meets these criteria with statistical data. The document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use, device description, principle of operation, materials, and technological characteristics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present within this 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is not available in a typical 510(k) submission focused on substantial equivalence:

1. A table of acceptance criteria and the reported device performance

No specific, quantifiable acceptance criteria or reported device performance metrics (e.g., in terms of snoring reduction percentage, AHI reduction) are stated in this 510(k) document for the devices Removable Acrylic Herbst, Allesee Snore Appliance (ASA), or Enoch Snorinator.

The "acceptance criteria" in the context of a 510(k) submission for these devices typically revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as the predicate. This is proven by similarity in:

• Intended Use: All devices share the intended use of reducing snoring and mild to moderate OSA by repositioning the lower jaw.
• Technological Characteristics: All devices are intraoral appliances designed to move the lower jaw forward.
• Materials: Implied to be similar to legally marketed devices (e.g., acrylic, stainless steel).
• Performance: Implied to be similar to legally marketed devices in their ability to reposition the jaw and alleviate snoring/OSA symptoms, although no specific performance data is presented.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical test set or performance study for these specific devices. The basis for substantial equivalence is comparison to predicate devices, not specific clinical performance data from a new study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as there is no reported test set or clinical study for these devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. These are mechanical intraoral devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. These are physical medical devices, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The substantial equivalence determination relies on comparing the device's characteristics and intended use to existing, legally marketed predicate devices, not on a new clinical ground truth establishment for novel performance claims.

8. The sample size for the training set

Not applicable. No training set is described as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth establishment is described.

Summary of Device and Predicate Information Present in the Document:

The 510(k) submission K070327 is for three intraoral devices:

1. Removable Acrylic Herbst
   • Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
   • Substantial Equivalence Claimed to: State University of New York at Buffalo, School of Dental Medicine, Removable Herbst Appliance.
2. Enoch Snorinator
   • Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
   • Substantial Equivalence Claimed to: Hays & Meade Inc., Snore Guard.
3. Allesee Snore Appliance (ASA)
   • Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
   • Substantial Equivalence Claimed to: Great Lakes Orthodontic Laboratory, NAPA Appliance.

In all cases, substantial equivalence is claimed based on similarities in intended use and device characteristics to predicate devices already on the market, which is a common pathway for mechanical medical devices in a 510(k) submission. The FDA's letter states that they reviewed the submission and determined "the device is substantially equivalent... for the indications for use stated in the enclosure." This administrative determination of substantial equivalence, rather than a clinical performance study with specific metrics, is the "proof" the document refers to.

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OptiBond All-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, lightcured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain. composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.

OptiBond All-In-One self-etching adhesive combines the ingredients needed for etching, priming, and bonding into a single adhesive solution, thereby eliminating separate etching and priming steps of the bonding process. OptiBond All-In-One adhesive can be used for the bonding of both direct and indirect restorations. The advantages of using OptiBond All-In-One adhesive include simplified bonding procedures and reduced post-operative sensitivity. OptiBond All-In-One incorporates the proven GPDM adhesive technology used in Optibond Solo Plus, fillers that contain fluoride and nano-fillers. This unique technology ensures the highest level of protection against microleakage while providing high bond strengths to a variety of substrates.

The provided text is a 510(k) summary for the Optibond All-In-One resin tooth bonding agent. It describes the device, its intended use, and claims substantial equivalence to a predicate device (GC America, Inc., G-Bond).

However, the document for K060469 does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria beyond the claim of substantial equivalence to an existing device.

The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it functions similarly and has the same intended use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing new clinical or performance study data with specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions requested based on the provided text, as this information is not present in the document. The 510(k) process for this device focused on demonstrating equivalence, not on a new performance study with acceptance criteria.

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TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or comparative effectiveness.

This document is a 510(k) premarket notification for a dental product called "TempBond Clear with Triclosan." It describes the device, its intended use, and claims substantial equivalence to another legally marketed device (Kerr Corporation, TempBond Clear). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot fulfill your request for the following reasons:

• No acceptance criteria: The document does not define any specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) that would be relevant for an AI/ML device.
• No study to prove device meets acceptance criteria: There is no study described that evaluates the performance of "TempBond Clear with Triclosan" against any set criteria. The approval is based on substantial equivalence to a predicate device, not on direct performance testing against clinical endpoints or statistical metrics relevant to AI.
• No information on AI/ML components: The device described is a dental cement, not an AI-powered diagnostic or therapeutic tool. Therefore, concepts like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this submission.

In summary, the provided text is a regulatory submission for a conventional medical device (dental cement) and does not involve AI/ML or the types of performance studies you've inquired about.

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The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.

The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.

The provided text is a 510(k) Summary of Safety and Effectiveness for a dental device, the Expasyl Power Applicator. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study report proving specific performance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for device performance cannot be extracted from this document.

The document primarily focuses on establishing that the Expasyl Power Applicator is substantially equivalent to the predicate device, Electro Medical Systems, EMS Air-Flow handy 2, for its intended use of dispensing a hemostatic/gingival retracting agent. Substantial equivalence in this context means the device performs in a similar manner and is intended for a similar use, rather than meeting specific quantitative performance metrics like a diagnostic AI model.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated with quantifiable measures. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This is a regulatory standard, not a performance metric like sensitivity or specificity.
• Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, precision). The document describes the device's function: "The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator." It also mentions "When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped." These are functional descriptions, not performance results from a study against specific acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document does not describe a performance study with a test set of data samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no performance study described with a ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. There is no performance study described requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a dental handpiece for dispensing paste, not an AI or diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. There is no performance study where ground truth was established.

8. The sample size for the training set:

• Not applicable. This document does not describe a machine learning algorithm or training set.

9. How the ground truth for the training set was established:

• Not applicable. There is no machine learning algorithm or training set.

In summary: The provided text is a 510(k) premarket notification for a dental handpiece, seeking substantial equivalence to a predicate device. It does not contain information about acceptance criteria, performance studies, test sets, ground truth establishment, or human-in-the-loop assessments as would be relevant for, for instance, an AI-powered diagnostic device.

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