510(k) K190998
K190998 is an FDA 510(k) premarket notification submitted by Apex Dental Materials, Inc. for the device "BA Pit & Fissure Sealant". The FDA issued a decision of Substantially Equivalent on November 8, 2019. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Apex Dental Materials, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2019
- Date Received
- April 16, 2019
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type