510(k) K140807
K140807 is an FDA 510(k) premarket notification submitted by Ortho Specialties for the device "COMPOSITE ORTHODONTIC BRACKETS". The FDA issued a decision of Substantially Equivalent on November 12, 2014. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Ortho Specialties has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2014
- Date Received
- April 1, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bracket, Plastic, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type