The following data is part of a premarket notification filed by Pacific Implant, Inc. with the FDA for Pacific Implant Titanium Endodontic Point.
| Device ID | K992582 |
| 510k Number | K992582 |
| Device Name: | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT |
| Classification | Point, Silver, Endodontic |
| Applicant | PACIFIC IMPLANT, INC. 2000 M. ST. N.W. 7TH FLOOR Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli PACIFIC IMPLANT, INC. 2000 M. ST. N.W. 7TH FLOOR Washington, DC 20036 |
| Product Code | EKL |
| CFR Regulation Number | 872.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-10-21 |
| Summary: | summary |