510(k) K992582
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1999
- Date Received
- August 2, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Point, Silver, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.3840
- Review Panel
- DE
- Submission Type