510(k) K120378
K120378 is an FDA 510(k) premarket notification submitted by Kuraray Medical, Inc. for the device "PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S". The FDA issued a decision of Substantially Equivalent on March 30, 2012. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kuraray Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2012
- Date Received
- February 7, 2012
- 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