The following data is part of a premarket notification filed by Excellence In Endodontics, Inc. with the FDA for Endodontic Pulp Canal Spreader.
| Device ID | K934714 |
| 510k Number | K934714 |
| Device Name: | ENDODONTIC PULP CANAL SPREADER |
| Classification | Scaler, Ultrasonic |
| Applicant | EXCELLENCE IN ENDODONTICS, INC. 11545 SORRENTO VALLEY RD. #313 San Diego, CA 92121 |
| Contact | Alan Donald |
| Correspondent | Alan Donald EXCELLENCE IN ENDODONTICS, INC. 11545 SORRENTO VALLEY RD. #313 San Diego, CA 92121 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1994-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195062030956 | K934714 | 000 |
| 00195062030789 | K934714 | 000 |
| 00195062030772 | K934714 | 000 |
| 00195062030765 | K934714 | 000 |
| 00195062030758 | K934714 | 000 |
| 00195062030741 | K934714 | 000 |
| 00195062030734 | K934714 | 000 |
| 00195062030727 | K934714 | 000 |
| 00195062030710 | K934714 | 000 |
| 00195062030703 | K934714 | 000 |
| 00195062030697 | K934714 | 000 |
| 00195062030680 | K934714 | 000 |
| 00195062030796 | K934714 | 000 |
| 00195062030802 | K934714 | 000 |
| 00195062030819 | K934714 | 000 |
| 00195062030949 | K934714 | 000 |
| 00195062030932 | K934714 | 000 |
| 00195062030925 | K934714 | 000 |
| 00195062030918 | K934714 | 000 |
| 00195062030901 | K934714 | 000 |
| 00195062030895 | K934714 | 000 |
| 00195062030888 | K934714 | 000 |
| 00195062030871 | K934714 | 000 |
| 00195062030864 | K934714 | 000 |
| 00195062030857 | K934714 | 000 |
| 00195062030833 | K934714 | 000 |
| 00195062030673 | K934714 | 000 |