510(k) K961089
K961089 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "PULPDENT ENDOPREP II". The FDA issued a decision of Substantially Equivalent on April 23, 1996. The device falls under product code EKL (Point, Silver, Endodontic), a Class I device regulated under 21 CFR 872.3840. Pulpdent Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1996
- Date Received
- March 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Point, Silver, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.3840
- Review Panel
- DE
- Submission Type