The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Sd Ceramic Coping For Quick Abutment, Locking. Model 45301. Rd Ceramic Coping For Quick Abutment, Locking, Model 45302..
| Device ID | K060530 |
| 510k Number | K060530 |
| Device Name: | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. |
| Classification | Teeth, Porcelain |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-05-22 |
| Summary: | summary |