The following data is part of a premarket notification filed by Vident with the FDA for Vita Hi-ceram.
Device ID | K902200 |
510k Number | K902200 |
Device Name: | VITA HI-CERAM |
Classification | Powder, Porcelain |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | E Morrow |
Correspondent | 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 | 1990-05-16 |
Decision Date | 1990-10-05 |