510(k) K173020
K173020 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "OBA-MCP, Orthodontic Bracket Adhesive with MCP". The FDA issued a decision of Substantially Equivalent on January 17, 2018. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Pulpdent Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2018
- Date Received
- September 28, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device Class
- Class II
- Regulation Number
- 872.3750
- Review Panel
- DE
- Submission Type