510(k) K182070
K182070 is an FDA 510(k) premarket notification submitted by BioHorizons Implant Systems, Inc. for the device "BioHorizons Tapered IM Implants". The FDA issued a decision of Substantially Equivalent on October 10, 2018. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2018
- Date Received
- August 1, 2018
- Clearance Type
- Special
- 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