510(k) K101545
K101545 is an FDA 510(k) premarket notification submitted by Keystone Dental for the device "GENESIS IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 2010. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Keystone Dental has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2010
- Date Received
- June 3, 2010
- Clearance Type
- Abbreviated
- 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