(46 days)
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.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (IMPREGUM® PENTA® M MONOSOFT) |
|---|---|---|
| Intended Use | Same as predicate device (IMPREGUM® PENTA®) | "IMPREGUM® PENTA® M MONOSOFT has the same intended use" |
| Operating Principle | Same as predicate device | "IMPREGUM® PENTA® M MONOSOFT is used by the same operating principle" |
| Chemical Design | Same basic chemical design as predicate device | "IMPREGUM® PENTA® M MONOSOFT incorporates the same basic chemical design" |
| Shelf Life | Same as predicate device | "IMPREGUM® PENTA® M MONOSOFT has the same shelf life" |
| Manufacturing/Packaging | Same materials and processes as predicate device | "IMPREGUM® PENTA® M MONOSOFT is manufactured and packaged using the same materials and processes" |
| Biocompatibility | No new biocompatibility issues raised by chemical composition | "All chemical components... are already part of the predicate device... or are contained in other 510(k) cleared impression materials... Therefore, we believe that additional biocompatibility testing is not required." |
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.
§ 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).