510(k) · Cleared

Cleared

Resolve 2.0

K152322510(k) TraditionalCleared Dec 16, 2015121-day reviewClass II21 CFR 872.3260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Denali Corporation · PME External Cleaning Solution

Cleared on Dec 16, 2015 as substantially equivalent to K925375 (Ultradent Products, Inc., 1993) after a 121-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Dec 16, 2015
Review: 121 days
Class: Class II
Product code: PME
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925375 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925375 Consepsis ScrubUltradent Products, Inc. · 1993
This deviceK152322 Resolve 2.0Denali Corporation · 2015
Descendant · cites it directly · 0 of its ownK163171 CeraCleanBisco, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all

K163171CeraCleanBisco, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925375	Consepsis Scrub	Ultradent Products, Inc.	1993	—
0 (this device)	K152322	Resolve 2.0	Denali Corporation	2015	—
+1	K163171	CeraClean	Bisco, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K152322, 1993–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 PME? 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

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K925375	Consepsis Scrub Summary page 4 …Cavity Varnish, Class II (21 CFR 872.3260, Product Code PME) REGISTRATION 3006367836 PRIMARY PREDICATE DEVICE Consepsis, Ultradent Products (k925375) EQUIVALENCE The predicate product has been found substantially equivalent und…	Ultradent Products, Inc.	1993	—

Also cleared against K925375: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K163171	CeraClean	Bisco, Inc.	2017	0

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.
Of its descendants, K163171 (Bisco, Inc., 2017) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K925375.

How does its category compare?

All PME devices

PME External Cleaning Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · PME

1in 2019

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PME

Too few PME 510(k)s in any year since 2007 to give a median.

Recalls per year · PME

No recall names PME since 2007.

Adverse event reports per year · PME

No MAUDE report names PME since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152322 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152322: Resolve 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152322

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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