510(k) K821625
K821625 is an FDA 510(k) premarket notification submitted by Roeko for the device "ENDODONTIC PAPERPOINTS". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code EKN (Point, Paper, Endodontic), a Class I device regulated under 21 CFR 872.3830.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1982
- Date Received
- June 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Point, Paper, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.3830
- Review Panel
- DE
- Submission Type