510(k) K113650
K113650 is an FDA 510(k) premarket notification submitted by Bonafix Surgical And Dental Implants, LLC for the device "ORTHOFIX SCREW". The FDA issued a decision of Substantially Equivalent on Oct 3, 2012. The device falls under product code OAT (Implant, Endosseous, Orthodontic), a Class II device regulated under 21 CFR 872.3640. Bonafix Surgical And Dental Implants, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 3, 2012
- Date Received
- Dec 12, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.