The following data is part of a premarket notification filed by Diamodent with the FDA for Ucla/universal Abutment.
Device ID | K993129 |
510k Number | K993129 |
Device Name: | UCLA/UNIVERSAL ABUTMENT |
Classification | Implant, Endosseous, Root-form |
Applicant | DIAMODENT 695 SOUTH MORNINGSTAR DR. Anaheim, CA 92808 |
Contact | Jeff Rassoli |
Correspondent | Jeff Rassoli DIAMODENT 695 SOUTH MORNINGSTAR DR. Anaheim, CA 92808 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-20 |
Decision Date | 2000-03-28 |