510(k) K992582
K992582 is an FDA 510(k) premarket notification submitted by Pacific Implant, Inc. for the device "PACIFIC IMPLANT TITANIUM ENDODONTIC POINT". The FDA issued a decision of Substantially Equivalent on October 21, 1999. The device falls under product code EKL (Point, Silver, Endodontic), a Class I device regulated under 21 CFR 872.3840. Pacific Implant, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1999
- Date Received
- August 2, 1999
- 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