Resolve 2.0

FDA 510(k) K152322 · Denali Corporation

Substantially Equivalent

510(k) numberK152322

Submission

Device name
Resolve 2.0
Applicant
Denali Corporation
Hanover, MA, US
Received
August 17, 2015
Decision date
December 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PME – External Cleaning Solution
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3260
Specialty
Dental

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

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Questions and answers

When was Resolve 2.0 cleared by the FDA?

Resolve 2.0 (K152322) received a 510(k) decision of Substantially Equivalent on December 16, 2015, 121 days after the submission was received.

What is the product code of K152322?

The FDA product code is PME – External Cleaning Solution, a Class II (moderate risk) device regulated under 21 CFR 872.3260.