Cleared Traditional

Resolve 2.0

K152322 · Denali Corporation · Dental

Dec 2015

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K152322 is an FDA 510(k) clearance for the Resolve 2.0, a External Cleaning Solution (Class II — Special Controls, product code PME), submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on December 16, 2015, 121 days after receiving the submission on August 17, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K152322 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2015
Decision Date	December 16, 2015
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PME — External Cleaning Solution
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3260
Definition	For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth.