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K Number
K991490
Device Name
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-07-15

(78 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K991489
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Alginate Impression Material II with water is used as a dental impression material.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information regarding the acceptance criteria or any study that proves the device meets specific performance criteria.

The document is a 510(k) clearance letter from the FDA for "Alginate Impression Material II". This letter primarily states that the device is substantially equivalent to a previously marketed device. It does not contain details about specific performance metrics, clinical studies, or the methodologies used to establish such performance.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance.
  3. Number or qualifications of experts.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How training set ground truth was established.

The document focuses on regulatory clearance through substantial equivalence, not on a detailed presentation of performance data or study design.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).