The following data is part of a premarket notification filed by Spofadental with the FDA for Impression Compound.
| Device ID | K110378 |
| 510k Number | K110378 |
| Device Name: | IMPRESSION COMPOUND |
| Classification | Material, Impression |
| Applicant | SPOFADENTAL 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman SPOFADENTAL 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-12 |
| Decision Date | 2011-04-05 |
| Summary: | summary |