510(k) K983120
K983120 is an FDA 510(k) premarket notification submitted by Oraltronics Marketing-Und Vertriebs GmbH for the device "BICORTICAL SCREW". The FDA issued a decision of Substantially Equivalent on Jul 29, 1999. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 1999
- Date Received
- Sep 4, 1998
- 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
- 510(k)