510(k) K822568
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1982
- Date Received
- August 24, 1982
- 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