510(k) K181476
K181476 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Prime&Bond active Universal Adhesive". The FDA issued a decision of Substantially Equivalent on Sep 28, 2018. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2018
- Date Received
- Jun 5, 2018
- 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
- 510(k)