510(k) · Cleared
ClearedVestogum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · ELW Material, Impression
Cleared on May 20, 1999 as substantially equivalent to K954192 (Espe GmbH & Co. Kg., 1995) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 20, 1999
- Review
- 38 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953027 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953027 Permadyne Penta (High & Low Viscosity)Espe GmbH & Co. Kg. · 1995
- This deviceK991221 VestogumEspe Dental AG · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953027 | Permadyne Penta (High & Low Viscosity) | Espe GmbH & Co. Kg. | 1995 | — |
| 0 (this device) | K991221 | Vestogum | Espe Dental AG | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954192 | Impregum PentaSummary page 1….....cccccceenneeeee Impression Material Common Name:.....cccccoevevnrneinceneennn. Gingiva Modeling Material Predicate Device IMPREGUM® PENTA by ESPE................. K 954192 PERMADYNE® PENTA H by ESPE .......... K 953027 Description for the Premarket Notification VESTOGUM® is classified as a dental i… | 1995 |
| * | K953027 | Permadyne Penta (High & Low Viscosity)Summary page 1…Name:.....cccccoevevnrneinceneennn. Gingiva Modeling Material Predicate Device IMPREGUM® PENTA by ESPE................. K 954192 PERMADYNE® PENTA H by ESPE .......... K 953027 Description for the Premarket Notification VESTOGUM® is classified as a dental impression material (21 C.F.R. § 872.3660) becau… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K954192.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
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…
Read the full statement (116 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991221: Vestogum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991221
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026