The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Sonicfill 2.
| Device ID | K143209 |
| 510k Number | K143209 |
| Device Name: | SonicFill 2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
| Contact | Kerri Casino |
| Correspondent | Kerri Casino SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841396116404 | K143209 | 000 |
| 00841396185274 | K143209 | 000 |
| 00841396185281 | K143209 | 000 |
| 00841396185298 | K143209 | 000 |
| 00841396185304 | K143209 | 000 |
| 10841396115919 | K143209 | 000 |
| 10841396115926 | K143209 | 000 |
| 10841396115933 | K143209 | 000 |
| 10841396115940 | K143209 | 000 |
| 10841396116398 | K143209 | 000 |
| 00841396185267 | K143209 | 000 |