The following data is part of a premarket notification filed by Sybron Endo/analytic with the FDA for Elements Obturation Unit.
| Device ID | K031664 |
| 510k Number | K031664 |
| Device Name: | ELEMENTS OBTURATION UNIT |
| Classification | Plugger, Root Canal, Endodontic |
| Applicant | SYBRON ENDO/ANALYTIC 15233 N.E. 90TH ST. Redmond, WA 98052 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON ENDO/ANALYTIC 15233 N.E. 90TH ST. Redmond, WA 98052 |
| Product Code | EKR |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-29 |
| Decision Date | 2004-04-28 |
| Summary: | summary |