The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primaconnex Rd And Wd Esthetic Contour Zi Abutments.
Device ID | K072572 |
510k Number | K072572 |
Device Name: | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
Contact | Karen Clement |
Correspondent | Karen Clement LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-12 |
Decision Date | 2007-10-05 |
Summary: | summary |