510(k) K152322
K152322 is an FDA 510(k) premarket notification submitted by Denali Corporation for the device "Resolve 2.0". The FDA issued a decision of Substantially Equivalent on December 16, 2015. The device falls under product code PME (External Cleaning Solution), a Class II device regulated under 21 CFR 872.3260. Denali Corporation has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2015
- Date Received
- August 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Cleaning Solution
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
For use on dental restorations, external to the mouth, prior to insertion into the mouth.