The following data is part of a premarket notification filed by Vident with the FDA for Vitadur Alpha Porcelain.
Device ID | K921623 |
510k Number | K921623 |
Device Name: | VITADUR ALPHA PORCELAIN |
Classification | Powder, Porcelain |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-06 |
Decision Date | 1992-07-02 |