510(k) K101504
K101504 is an FDA 510(k) premarket notification submitted by Essential Dental Systems, Inc. for the device "TI-CORE FLOW". The FDA issued a decision of Substantially Equivalent on October 29, 2010. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Essential Dental Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2010
- Date Received
- June 1, 2010
- 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