510(k) K926121
K926121 is an FDA 510(k) premarket notification submitted by Dentmed , Ltd. for the device "BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Dentmed , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1994
- Date Received
- December 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Cartridge
- Device Class
- Class II
- Regulation Number
- 872.6770
- Review Panel
- DE
- Submission Type