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Gingiva Modeling Material for:
Combination works when choosing and mounting the attachment, the papilla is fully preserved
Telescopic works the shoulder of the crowns to be cut is indicated according to the gingiva contour
Anterior tooth area with regard to esthetics and periodontal hygienics, the forming possibilities of the interdental spaces are increased
Forming of different tooth lengths according to the natural conditions in the patient's mouth, they can be adapted in anatomically correct way; especially in bridge spans
Color rating of the veneer material the material which is in color adapted to the gingiva, serves for more precise color matching
Controlled modellation the cervical-incisal crown convexity for the protection of the gingival margin can be controlled

VESTOGUM® is classified as a dental impression material (21 C.F.R. § 872.3660) because it is a device intended to be one step in the process to reproduce the structure of a patient's gums. VESTOGUM® serves for making a gingiva model. Because of exposing the preparation border on the master cast, there is an essential lack of information with regard to the impressed soft tissues. The gingiva modeling material on polyether basis, in color adapted to the natural gingiva, is a controlling material in order to avoid a displacement of the marginal periodontium due to overcontuored crowns. VESTOGUM® thus contributes considerably to a periodontally hygienic functional and esthetic prosthesis. VESTOGUM® consists of the same ingredients as IMPREGUM® PENTA, ESPE's proven and well-established polyether based impression material except one pigment. This pigment, however, is contained in ESPE's polyether based impression material PERMADYNE® PENTA H.

The provided text is a 510(k) summary for VESTOGUM®, a dental impression material, and does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, I am unable to provide the requested information based on the input document. The document primarily discusses the device's classification, intended use, and its substantial equivalence to previously approved predicate devices (IMPREGUM® PENTA and PERMADYNE® PENTA H). It mentions that no new toxicology and biocompatibility studies were deemed necessary due to the material's composition being similar to existing, well-established products.

The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or ground truth establishment details for a performance study.
• The number or qualifications of experts, or adjudication methods for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone (algorithm-only) performance study.
• The sample size for a training set or how ground truth was established for it.

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