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K Number
K013859
Device Name
RHODIA BITE REGISTRATION MATERIAL
Manufacturer
RHODIA INC.
Date Cleared
2002-01-29

(69 days)

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

Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

Device Description

The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto a tray. The material quickly cures into a rigid impression.

AI/ML Overview

The provided text describes a 510(k) notification for Rhodia Bite Registration Material, a dental impression material. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

  • Device Identification: Proprietary name, common name, product code, manufacturer, and contact information.
  • Device Description: Two-part vinyl polysiloxane paste for taking impressions of biting surfaces to set gypsum casts.
  • Substantial Equivalence Claim: The device is claimed to be substantially equivalent to preamendment vinyl polysiloxane dental impression materials and was tested according to existing guidance.
  • FDA Clearance Letter: Confirmation of 510(k) clearance and the regulatory framework.
  • Indications for Use: The intended purpose of the device.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

  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 the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) 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

§ 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).