The following data is part of a premarket notification filed by Williams Gold Refining Co., Inc. with the FDA for Presolder For Non-precious Dental Alloys.
Device ID | K811563 |
510k Number | K811563 |
Device Name: | PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS |
Classification | Alloy, Other Noble Metal |
Applicant | WILLIAMS GOLD REFINING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-04 |
Decision Date | 1981-07-28 |