# K991425: Xantopren Comfort

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Jun 15, 1999 after 53 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 K910165 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910165: Cuttersil Mucosa, Heraeus Kulzer, Inc. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K760756: Battery Operated Flow Rate Computer, 3M Health Care, Sarns (1976). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K991425
Methodology: https://510kreport.com/methodology