510(k) K131097
K131097 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "LEGACY3 6MM LENGTH IMPLANTS". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Implant Direct Sybron Manufacturing, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2013
- Date Received
- April 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type