510(k) K131043
K131043 is an FDA 510(k) premarket notification submitted by Apex Dental Materials, Inc. for the device "APEX UNIVERSAL ADHESIVE". The FDA issued a decision of Substantially Equivalent on September 10, 2013. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Apex Dental Materials, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2013
- Date Received
- April 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type