510(k) K030243
K030243 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314". The FDA issued a decision of Substantially Equivalent on April 23, 2003. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Imtec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2003
- Date Received
- January 23, 2003
- 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