510(k) K143667
K143667 is an FDA 510(k) premarket notification submitted by Gc Orthodontics America, Inc. for the device "GC KommonBase". The FDA issued a decision of Substantially Equivalent on May 7, 2015. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Gc Orthodontics America, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2015
- Date Received
- December 23, 2014
- 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