510(k) · Cleared
ClearedXantopren Comfort
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · ELW Material, Impression
Cleared on Jun 15, 1999 as substantially equivalent to K910165 (Heraeus Kulzer, Inc., 1991) after a 53-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 15, 1999
- Review
- 53 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910165 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910165 Cuttersil MucosaHeraeus Kulzer, Inc. · 1991
- This deviceK991425 Xantopren ComfortHeraeus Kulzer, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910165 | Cuttersil Mucosa | Heraeus Kulzer, Inc. | 1991 | — |
| 0 (this device) | K991425 | Xantopren Comfort | Heraeus Kulzer, Inc. | 1999 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K760756 | FDA’s K760756 is Battery Operated Flow Rate Computer Our OCR of the scanned summary read K760756, FDA’s number for Battery Operated Flow Rate Computer (3M Health Care, Sarns). Its FDA name has none of the distinctive words the summary uses for the device it names, “CutterSil Light”. Kept off the family tree. Summary page 1…ette Blvd. South Bend, IN. Contact: Cheryl V. Zimmerman 219-299-6662 Device: Xantopren Cornfort Base Xantopren Activator Substantially Equivalent to: CutterSil Light [K760756] CutterSil Mucosa [K910165] CutterSil Universal Hardener (Paste & Liquid) [K760756]) Device Description: Xantopren Comfort is a… | 1976 |
| * | K910165 | Cuttersil MucosaSummary page 1…Contact: Cheryl V. Zimmerman 219-299-6662 Device: Xantopren Cornfort Base Xantopren Activator Substantially Equivalent to: CutterSil Light [K760756] CutterSil Mucosa [K910165] CutterSil Universal Hardener (Paste & Liquid) [K760756]) Device Description: Xantopren Comfort is a is silicone based condensa… | 1991 |
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?
- Its one ancestor has no recall.
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?
Xantropren Comfort is a silicone based condensation curing impression material
used for all inlay, crown and bridge, edentulous and partial impressions. The
Xantropren Comfort Activator is the catalyst. This product is packaged in a
cartridge delivery system which will dispense equal amounts of base and
activator.
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/K991425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991425: Xantopren Comfort.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991425
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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