510(k) K152247
K152247 is an FDA 510(k) premarket notification submitted by Dentsply International, Inc. for the device "ATLANTIS Crown". The FDA issued a decision of Substantially Equivalent on January 29, 2016. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Dentsply International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2016
- Date Received
- August 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type