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Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is intended for the fabrication of methacrylate-based orthodontic appliances and is intended for use when aesthetically clear acrylic appliances, such as orthodontic retainers, are desired.

Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin

This document is a 510(k) premarket notification letter from the FDA regarding a dental resin, not a study evaluating a device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from this document.

The document is a clearance letter stating that the Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is substantially equivalent to legally marketed predicate devices. It describes the product's intended use and the regulatory framework it falls under. It does not contain any performance data or a study description.

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LANG DENTAL Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopague acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent

Lang Dental Jet XR Radiopaque Acrylic Resin is a high quality self curing 2-part system. The system is formed by a powder polymer and liquid monomer. The combination of powder polymer and liquid monomer is converted into a hard methacrylate finished product. Lang Dental Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based actylic appliances that require radiopacity.

The provided text describes a 510(k) submission for the "Lang Dental Jet XR Radiopaque Acrylic Resin" and does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Instead, the document focuses on:

• Device Identification: Trade Name (Jet XR), Common Name (Radiopaque Acrylic Resin), Classification Name (Dental Product), Product Code (EBI).
• Intended Use: Fabrication of methacrylate-based acrylic appliances and use where a radiopaque acrylic dental device is useful in establishing anatomical location or site (e.g., provisional implant stent).
• Technological Characteristics: It's a methyl methacrylate resin compound, identical to the predicate (OrthoJet Acrylic Resin) except for the addition of Barium Sulfate for radiopacity.
• Performance Data:
  • Non-Clinical Data: Physical property tests (flexural strength, modulus, sorption, and solubility) were conducted. The conclusion was that performance characteristics "appeared adequate" because the product is not under stress in its intended diagnostic applications, and no ISO or ADA standards exist for provisional restorative or diagnostic products.
  • Clinical Data: None was submitted, as the chemical composition was nearly identical to the predicate, with Barium Sulfate having established biocompatibility.
• Conclusion of Substantial Equivalence (SE): The product was deemed substantially equivalent to the predicate because it's for diagnostic purposes, and its chemical composition is essentially the same as the predicate, with the addition of biocompatible radiopaque Barium Sulfate.

Therefore, I cannot fulfill your request for the tables and details of a study proving acceptance criteria, as this information is explicitly stated as not present in the provided 510(k) summary. The submission relied on the substantial equivalence to a predicate device and existing knowledge of the added component's biocompatibility, rather than a new clinical performance study.

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LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.

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This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or study data for device performance. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or details about training sets.

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LANG DENTAL Acrylic Primer is intended for use as an acrylic bonding agent when adding new acrylic to existing denture base acrylic.

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The provided document is a 510(k) premarket notification letter from the FDA for a dental device (Lang Dental Acrylic Primer). This type of document does not contain any information about acceptance criteria or specific study data to prove device performance.

Instead, a 510(k) letter confirms that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent to a legally marketed predicate device. This means the device is considered as safe and effective as existing devices on the market, based on its indications for use and technological characteristics. The letter is an official approval to market the device, subject to general controls.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications from this document. Such information would typically be found in the actual 510(k) submission itself (which is not provided here), or in a separate clinical or non-clinical study report.

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LANG DENTAL TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN is intended for the fabrication of denture relines.

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I am sorry, but based on the provided document, I cannot answer the request. The document is a 510(k) clearance letter from the FDA for a dental device, specifically "Lang Dental Tempo Cushion Treatment Denture Reline Acrylic Resin." This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries. The letter only states that the device is "substantially equivalent" to existing devices for the purpose of "fabrication of denture relines."

Therefore, I cannot extract the following information from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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LANG DENTAL RESINCAP PATTERN AND COPING ACR YLIC RESIN is intended for the fabrication of patterns and copings.

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This document is a 510(k) premarket notification approval letter for a dental acrylic resin. It is a regulatory document and does not contain any information about acceptance criteria or a study proving device performance as requested. The letter confirms that the device, "Lang Dental Resincap Pattern and Coping Acrylic Resin," is substantially equivalent to legally marketed predicate devices for its intended use in "the fabrication of patterns and copings."

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies against acceptance criteria.

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Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin.

The provided document is an FDA 510(k) clearance letter for a dental resin. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily focused on the substantial equivalence determination for the Lang Dental Resin A97 Fibred Pink.

Therefore, I cannot extract the requested information as it is not present in the given text.

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