(36 days)
Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst, used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.
Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst. Polyvinyl Siloxane Adhesive is an adhesive material.
This document is a 510(k) summary for material modifications to dental impression materials and an adhesive, not a study involving a medical device with an algorithm or AI. Therefore, most of the requested fields are not applicable.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimension® Penta | Meets requirements of relevant DIN, ISO, and ADA standards for impression material. |
| Dimension® Garant L | Meets requirements of relevant DIN, ISO, and ADA standards for impression material. |
| Polyvinyl Siloxane Adhesive | Adhesion power compared to Permagum® Adhesive. (Specific quantitative results not provided, but implies success in comparison). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes physical and performance characteristic comparisons to predicate devices, but does not detail the sample sizes for these tests. The provenance is from ESPE, a German company (submission by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany). All data would be prospective testing of the modified materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant here as this is about physical and performance characteristics of materials tested against established standards and predicate devices.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are relevant for subjective assessments, typically in imaging or diagnostic studies. This document describes objective material property testing.
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 not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used
- Established Standards and Predicate Device Performance: For Dimension® Penta and Dimension® Garant L, the "ground truth" is defined by the technical requirements of relevant DIN, ISO, and ADA standards for impression materials. For Polyvinyl Siloxane Adhesive, the "ground truth" for comparison is the performance of the predicate device, Permagum® Adhesive.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/ML device.
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MAR 15 1996
II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for silicone impression material, tradenamed Permagum® (K812116) and Permagum® Garant Light (K890720), to create slightly modified impression material, referred to by the tradenames Dimension® Penta and Dimension® Garant L. For Dimension® Penta, the reason for this modification is solely to improve user convenience by allowing mixing of the impression material through use of a free-standing electronic mixing apparatus (Pentamix) and to enhance the stability of the impression material. For Dimension® Garant L, the reason for this modification is also to enhance user convenience by allowing mixing and dispensing of the impression material through use of a hand-held automatic mixing and dispensing apparatus (Garant Dispenser). Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst, used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws.
ESPE's 510(k) submission also includes adhesive material, tradenamed Polyvinyl Siloxane Adhesive, which is a modification of ESPE's previously cleared Permagum® Adhesive (K881838). The reason for the modification in adhesive material is to enhance the user's ability to create a uniform layer of the adhesive on the tray, to enhance the product's adhesion power and to
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accommodate workplace preferences. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.
For Dimension® Penta and Dimension® Garant L, ESPE is claiming substantial equivalence to its previously cleared Permagum® and Permagum® Garant Light products, respectively. Both sets of products have the same intended use and the same principal ingredient composition. The percentage at which certain components are present in the impression material, however, has been changed in order to improve product viscosity and mixability of the impression material to enable use of the products in conjunction with an automatic mixing apparatus. In addition, several new pigments have been added to the base paste and catalyst to allow for varying impression colors. Finally, several ingredients at relatively insignificant amounts have been added to the new material in order to enhance product stability and mixability.
For Polyvinyl Siloxane Adhesive, ESPE is claiming substantial equivalence to its previously cleared Permagum® Adhesive. Both products have the same intended use, and two of the three product ingredients remain the same. The percentage at which two of the three product components are present in the adhesive material, however, has been slightly changed in order to
WA01A/A25345.1
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enhance the user's ability to create a uniform layer of the adhesive on the tray, and also to enhance the product's overall adhesion power. In addition, one ingredient has been substituted for another in order to accommodate workplace preferences.
To support substantial equivalence to predicate products, the physical and performance characteristics of Dimension® Penta have been compared to those of Permagum®, and the physical and performance characteristics of Dimension® Garant L to those of Permagum® Garant Light. The relevant performance characteristic of Polyvinyl Siloxane Adhesive (adhesion power) has been compared to that of Permagum® Adhesive. Dimension® Penta and Dimension® Garant L meet the requirements of relevant DIN, ISO and ADA standards for impression material.
ESPE's 510(k) has been submitted on February 5, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
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§ 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).