510(k) K962743
K962743 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "PULPDENT SODIUM HYPOCHLORITE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 6, 1996. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Pulpdent Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1996
- Date Received
- July 15, 1996
- 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