The following data is part of a premarket notification filed by Deepak Products, Inc. with the FDA for Gelato Prophylaxis Paste.
| Device ID | K042048 |
| 510k Number | K042048 |
| Device Name: | GELATO PROPHYLAXIS PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | DEEPAK PRODUCTS, INC. 5220 NW 72ND AVE., BAY #15 Miami, FL 33166 |
| Contact | Ricardo A Carles |
| Correspondent | Ricardo A Carles DEEPAK PRODUCTS, INC. 5220 NW 72ND AVE., BAY #15 Miami, FL 33166 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2004-10-26 |