The following data is part of a premarket notification filed by Sunstar Americas, Inc. with the FDA for Butler Calci-flor Prophylaxis Paste.
| Device ID | K102053 |
| 510k Number | K102053 |
| Device Name: | BUTLER CALCI-FLOR PROPHYLAXIS PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | SUNSTAR AMERICAS, INC. 10 E. SCANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Contact | Carl Jenkins |
| Correspondent | Carl Jenkins SUNSTAR AMERICAS, INC. 10 E. SCANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-22 |
| Decision Date | 2011-02-03 |
| Summary: | summary |