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K Number
K020287
Device Name
DENTITION INTEGRATING MATERIAL
Manufacturer
PULPDENT CORPORATION
Date Cleared
2002-04-12

(74 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

Device Description

Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

AI/ML Overview

The provided text is a 510(k) premarket notification for a dental material. It states that the device, PULPDENT DENTITION INTEGRATING MATERIAL, is substantially equivalent to predicate devices. It does not contain a study with acceptance criteria and device performance results as requested.

The document focuses on demonstrating substantial equivalence based on design, composition, performance, intended use, safety, and effectiveness compared to existing devices. It mentions that chemical ingredients are used in predicate products and that "laboratory testing has shown that Dentifian Integrating Material is equivalent in physical and mechanical properties to the predicate products." However, it does not provide specific details of these laboratory tests, the acceptance criteria used, or the reported performance data.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
  2. Sample size used for the test set and the data provenance: Not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no specific performance study with a test set is detailed.
  4. Adjudication method: Not applicable.
  5. MRMC comparative effectiveness study: Not conducted or reported in the document. This is a material, not an AI device.
  6. Standalone performance (algorithm only): Not applicable. This is a material, not an AI algorithm.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document concludes with the FDA's approval of the 510(k) premarket notification, indicating that the device is considered substantially equivalent to already marketed predicate devices.

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.