510(k) K040714
K040714 is an FDA 510(k) premarket notification submitted by Innova Corp. for the device "HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on April 9, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Innova Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2004
- Date Received
- March 18, 2004
- 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