The following data is part of a premarket notification filed by Usbiomaterials Corp. with the FDA for Butler Gum Prophy Paste With Novamin.
| Device ID | K024343 |
| 510k Number | K024343 |
| Device Name: | BUTLER GUM PROPHY PASTE WITH NOVAMIN |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | USBIOMATERIALS CORP. 13709 PROGRESS BLVD. #23 Alachua, FL 32615 |
| Contact | David C Greenspan |
| Correspondent | David C Greenspan USBIOMATERIALS CORP. 13709 PROGRESS BLVD. #23 Alachua, FL 32615 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-27 |
| Decision Date | 2003-07-11 |
| Summary: | summary |