510(k) K884533
K884533 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1989
- Date Received
- October 28, 1988
- 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