510(k) K914714
K914714 is an FDA 510(k) premarket notification submitted by Implant Corp. of America for the device "BONE DRILLS OR TAPS". The FDA issued a decision of Substantially Equivalent on November 15, 1993. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Implant Corp. of America has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1993
- Date Received
- October 18, 1991
- 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