The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Zircon-f Prophylaxis Paste.
| Device ID | K040988 |
| 510k Number | K040988 |
| Device Name: | ZIRCON-F PROPHYLAXIS PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue, WA 98004 |
| Contact | Vincent M Tentarelli |
| Correspondent | Vincent M Tentarelli PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue, WA 98004 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-15 |
| Decision Date | 2004-07-07 |
| Summary: | summary |