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K Number
K994193
Device Name
IMPREGUM PENTA DUOSOFT
Manufacturer
ESPE DENTAL AG
Date Cleared
2000-01-28

(46 days)

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

Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PENTAMIX® 2 mixing device, resp .:

Impressions for inlay, onlay, crown, and bridge restorations

Functional impressions

Fixation impressions

Implant impressions

Device Description

IMPREGUM® PENTA® DUOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a dental impression material called IMPREGUM® PENTA® DUOSOFT. It states that the device is substantially equivalent to a predicate device, PERMADYNE® PENTA®, and therefore, no new studies demonstrating performance against acceptance criteria were conducted or presented.

The basis for substantial equivalence is primarily that the new device uses the same materials and processes for manufacturing and packaging as the predicate device. Furthermore, all chemical components of the new device are either present in the predicate device or in other 510(k) cleared impression materials manufactured by ESPE.

Therefore, the following information cannot be extracted from the provided text as the application relies on substantial equivalence to a predicate device rather than new performance studies with specific acceptance criteria:

  1. A table of acceptance criteria and the reported device performance: Not applicable, as performance against new acceptance criteria was not presented.
  2. Sample size used for the test set and the data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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 is a dental impression material, not an AI diagnostic device.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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).