510(k) K922250
K922250 is an FDA 510(k) premarket notification submitted by Essential Dental Systems, Inc. for the device "FLEXI-FLOW CEMENT WITH TITANIUM". The FDA issued a decision of Substantially Equivalent on January 26, 1994. 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
- January 26, 1994
- Date Received
- May 6, 1992
- 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