510(k) K141503
K141503 is an FDA 510(k) premarket notification submitted by Denali Corporation for the device "DENALI 501CEMENT". The FDA issued a decision of Substantially Equivalent on November 10, 2014. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Denali Corporation has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2014
- Date Received
- June 6, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type