# K130680: Acrytone, Rezen NF, and Iso Fast Denture Resins

- Pathway: 510(k) (Traditional)
- Applicant: Dentsoll, Inc.
- Decided: Jul 26, 2013 after 135 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902115 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110037: Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid, Heraeus Kulzer, LLC (2011)

## Cited in the summary but kept off the family tree
- K121360: Biodesign Ent Repair Graft, Cook Biotech Incorprated (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170375: Nobilplast Denture Resin (2017), 0 descendants of its own

## Indications for use
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

Source page: https://510kreport.com/device/K130680
Methodology: https://510kreport.com/methodology