510(k) K093321
K093321 is an FDA 510(k) premarket notification submitted by BioHorizons Implant Systems, Inc. for the device "BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 2, 2010. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. BioHorizons Implant Systems, Inc. has 40 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2010
- Date Received
- Oct 23, 2009
- 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
- 510(k)