The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Esthetic Zirconia Abutment.
Device ID | K031719 |
510k Number | K031719 |
Device Name: | ESTHETIC ZIRCONIA ABUTMENT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Elizabeth J Mason |
Correspondent | Elizabeth J Mason NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-03 |
Decision Date | 2003-07-02 |
Summary: | summary |