510(k) K150727
K150727 is an FDA 510(k) premarket notification submitted by Tokuyama Dental Corporation for the device "ESTECEM". The FDA issued a decision of Substantially Equivalent on Jun 17, 2015. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Tokuyama Dental Corporation has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2015
- Date Received
- Mar 20, 2015
- 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
- 510(k)