510(k) K962733
K962733 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)". The FDA issued a decision of Substantially Equivalent on Oct 11, 1996. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Union Broach, Div. Moyco Industries, Inc. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 1996
- Date Received
- Jul 15, 1996
- 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)