510(k) K110796
K110796 is an FDA 510(k) premarket notification submitted by Biomers Products, LLC for the device "SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE". The FDA issued a decision of Substantially Equivalent on March 31, 2011. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Biomers Products, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2011
- Date Received
- March 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Bracket, Plastic, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type