The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Blo2x Oxygen Blocker.
| Device ID | K102526 |
| 510k Number | K102526 |
| Device Name: | BLO2X OXYGEN BLOCKER |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2010-10-22 |
| Summary: | summary |