510(k) K800291
K800291 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "ENDEX REAMERS PULP CANAL, ENDODONTIC". The FDA issued a decision of Substantially Equivalent on February 19, 1980. The device falls under product code EKP (Reamer, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1980
- Date Received
- February 11, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reamer, Pulp Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type