510(k) · Cleared
ClearedCosmopost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · ELR Post, Root Canal
Cleared on Sep 17, 1997 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 17, 1997
- Review
- 44 days
- Class
- Class I
- Product code
- ELR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All ELR devicesELR Post, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELR
FDA has decided no ELR device since 2007.
Median 510(k) review, days · ELR
Too few ELR 510(k)s in any year since 2007 to give a median.
Recalls per year · ELR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELR
1in 2025
MAUDE reports naming product code ELR, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 5 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972875: Cosmopost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026