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

Impressions for inlay, onlay, crown, and bridge restorations

Functional impressions

Fixation impressions

Implant impressions

IMPREGUM® PENTA® M MONOSOFT 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. ESPE is submitting this Special 510(k) for modifications to its polyether based impression material IMPREGUM® PENTA®. The modified material is characterized by its reduced Shore hardness in comparison to IMPREGUM® PENTA®. The reduced Shore hardness of the set impression material results in increased user convenience because the set impression is easier to remove from the mouth. As an additional effect of the reduced Shore hardness, slight undercuts have no longer to be blocked out. The name of the modified material will be, however, IMPREGUM® PENTA® M MONOSOFT. Like IMPREGUM® PENTA®, IMPREGUM® PENTA® M MONOSOFT is an impression material designed for the monophase technique. Like for example IMPREGUM® PENTA® and PERMADYNE® PENTA®, IMPREGUM® PENTA® MONOSOFT is another material intended to be used in ESPE's automatic mixing, dosing and dispensing device, PENTAMIX®.

Acceptance Criteria and Study for IMPREGUM® PENTA® M MONOSOFT

This response is based on the provided 510(k) summary for IMPREGUM® PENTA® M MONOSOFT (K994192).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on modifications to an existing device (IMPREGUM® PENTA®) rather than a de novo submission. Therefore, the "acceptance criteria" are implicitly defined by the demonstration of substantial equivalence to the predicate device, IMPREGUM® PENTA®, particularly regarding its physical and mechanical properties. The key modification is explicitly stated as reduced Shore hardness. The performance is demonstrated by directly comparing the modified material's properties to the unmodified predicate.

Note regarding "Reduced Shore hardness": While this is a change in a physical property, it's presented as an improvement in "user convenience" and not as failing a specific functional acceptance criterion for the intended use. The underlying assumption is that the reduced hardness still allows the material to function effectively as an impression material for its stated indications. The document implies that this change does not negatively impact the clinical performance required for substantial equivalence. No specific quantitative targets or thresholds for Shore hardness are provided as "acceptance criteria."

2. Sample Size and Data Provenance

The document does not specify a separate "test set" and thus, no sample sizes for a test set are provided. The "study" described is a comparison of the modified device's characteristics to the predicate device.

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation, but rather a comparison of defined properties. The document mentions "the physical and mechanical properties" being compared.
• Data Provenance: The document identifies the submitter as "ESPE Dental AG" in "Seefeld, Bavaria, Germany," suggesting the studies and data originate from Germany. The document does not specify if the data is retrospective or prospective, but given it's a comparison of material properties, it is likely based on laboratory testing.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This submission is for a material modification of a dental impression material, evaluated through physical and chemical properties, not a diagnostic device requiring expert interpretation of results. Therefore, no experts were used to establish "ground truth" in the diagnostic sense.

4. Adjudication Method

Not applicable. No "adjudication method" is described as this is not a study involving human reader interpretation or clinical outcomes requiring independent review for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This device is a dental impression material, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. A standalone performance study (in the context of an algorithm's performance) was not done. This is a material science modification, not an algorithm.

7. Type of Ground Truth

The "ground truth" for this submission is implicitly the established physical, mechanical, and chemical properties of the predicate device (IMPREGUM® PENTA®) and standard material science test methods. The modified device's properties are compared against these benchmarks, with the key difference (reduced Shore hardness) presented as beneficial for user convenience.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth established for one.

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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

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.

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.

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