The following data is part of a premarket notification filed by Vident with the FDA for In-ceram Spinell Kit For Celav Model V56-001/e63013.
Device ID | K960480 |
510k Number | K960480 |
Device Name: | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 |
Classification | Teeth, Porcelain |
Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-02 |
Decision Date | 1996-03-15 |