510(k) K860569
K860569 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "ENDODONTIC ROOT CANAL PLUGGER". The FDA issued a decision of Substantially Equivalent on March 26, 1986. The device falls under product code EKR (Plugger, Root Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Dentsply Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1986
- Date Received
- February 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plugger, Root Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type