510(k) K830814
K830814 is an FDA 510(k) premarket notification submitted by Endodent, Inc. for the device "POINT, PAPER ENDODONTIC". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Endodent, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1983
- Date Received
- March 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type