The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Dental Alginate Impression Material.
Device ID | K790595 |
510k Number | K790595 |
Device Name: | DENTAL ALGINATE IMPRESSION MATERIAL |
Classification | Material, Impression |
Applicant | WALLACE A. ERICKSON & CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-26 |
Decision Date | 1979-06-15 |