510(k) K150750
K150750 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray". The FDA issued a decision of Substantially Equivalent on Jul 2, 2015. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2015
- Date Received
- Mar 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)