(36 days)
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No
The device is a dental impression material and adhesive, with no mention of AI or ML in the description, intended use, or performance studies.
No
The device is an impression material used to make molds of teeth and jaws, not to treat a disease or condition.
No
This device is an impression material used to make physical molds of dental structures, not to diagnose a medical condition.
No
The device is described as a polyvinyl siloxane impression material and an adhesive material, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to make impressions of anatomical structures (inlay, onlay, crown and bridge preparations, and edentulous jaws). This is a physical process for creating a mold of a body part.
- Device Description: The device is an impression material and an adhesive. These are materials used for physical molding.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The device is a dental impression material, which is a type of medical device used in dentistry for diagnostic and treatment planning purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst.
Polyvinyl Siloxane Adhesive is composed of three ingredients, one of which has been substituted from the previous version.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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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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