510(k) K860817
K860817 is an FDA 510(k) premarket notification submitted by Pacific Union Dental, Inc. for the device "ROOT CANAL ORGANIZER". The FDA issued a decision of Substantially Equivalent on March 17, 1986. The device falls under product code EIK (Carver, Wax, Dental), a Class I device regulated under 21 CFR 872.4565. Pacific Union Dental, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1986
- Date Received
- March 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Wax, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type