The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sonicfill 2010.
| Device ID | K091091 |
| 510k Number | K091091 |
| Device Name: | SONICFILL 2010 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. 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 | 2009-04-16 |
| Decision Date | 2009-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100720000 | K091091 | 000 |