# K152322: Resolve 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: Dec 16, 2015 after 121 days
- Product code: PME (External Cleaning Solution)
- Device class: 2
- Regulation: 21 CFR 872.3260
- 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 K925375 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925375: Consepsis Scrub, Ultradent Products, Inc. (1993) Summary page 4.

## Most influential descendants
- K163171: CeraClean (2017), 0 descendants of its own

## Indications for use
Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Source page: https://510kreport.com/device/K152322
Methodology: https://510kreport.com/methodology