510(k) K123615
K123615 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "IRIS - HIGH STRENGTH GLASS CERAMIC". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Dentsply Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2013
- Date Received
- November 23, 2012
- 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