# K991221: Vestogum

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: May 20, 1999 after 38 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953027 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954192: Impregum Penta, Espe GmbH & Co. Kg. (1995) Summary page 1.
- K953027: Permadyne Penta (High & Low Viscosity), Espe GmbH & Co. Kg. (1995) Summary page 1.

## Indications for use
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 coritour 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

Source page: https://510kreport.com/device/K991221
Methodology: https://510kreport.com/methodology