510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152322Substantially Equivalent

Resolve 2.0

Denali Corporation, Hanover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152322 is the FDA 510(k) clearance record for Resolve 2.0, a class II device, cleared for Denali Corporation on under FDA product code PME (External Cleaning Solution). FDA's definition for product code PME reads: "For use on dental restorations, external to the mouth, prior to insertion into the mouth". FDA records list 9 510(k) clearances for Denali Corporation, from to . As of , FDA records show no recalls naming K152322.

Clearance record

Decision date
Received
(121 days to decision)
Product code
PME External Cleaning Solution
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Denali Corporation 134 Old Washington St., Hanover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PME

Trailing 12 months

FDA records hold no clearances under product code PME in the trailing twelve months.

FDA records show no clearances under product code PME in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260