The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primasolo One-piece Implants & Healing Caps.
| Device ID | K050506 |
| 510k Number | K050506 |
| Device Name: | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D76815400K0 | K050506 | 000 |
| D76815413K0 | K050506 | 000 |
| D76815414K0 | K050506 | 000 |
| D76815415K0 | K050506 | 000 |
| D76815416K0 | K050506 | 000 |
| D76815417K0 | K050506 | 000 |
| D76815418K0 | K050506 | 000 |
| D76815419K0 | K050506 | 000 |
| D76815420K0 | K050506 | 000 |
| D76815421K0 | K050506 | 000 |
| D76815412K0 | K050506 | 000 |
| D76815411K0 | K050506 | 000 |
| D76815410K0 | K050506 | 000 |
| D76815401K0 | K050506 | 000 |
| D76815402K0 | K050506 | 000 |
| D76815403K0 | K050506 | 000 |
| D76815404K0 | K050506 | 000 |
| D76815405K0 | K050506 | 000 |
| D76815406K0 | K050506 | 000 |
| D76815407K0 | K050506 | 000 |
| D76815408K0 | K050506 | 000 |
| D76815409K0 | K050506 | 000 |
| D76815422K0 | K050506 | 000 |
| D76815423K0 | K050506 | 000 |
| D76815424K0 | K050506 | 000 |
| D76815437K0 | K050506 | 000 |
| D76845000K0 | K050506 | 000 |
| D76845001K0 | K050506 | 000 |
| D76845002K0 | K050506 | 000 |
| D76845003K0 | K050506 | 000 |
| D76815227K0 | K050506 | 000 |
| D76815228K0 | K050506 | 000 |
| D76815229K0 | K050506 | 000 |
| D76815230K0 | K050506 | 000 |
| D76815436K0 | K050506 | 000 |
| D76815435K0 | K050506 | 000 |
| D76815434K0 | K050506 | 000 |
| D76815425K0 | K050506 | 000 |
| D76815426K0 | K050506 | 000 |
| D76815427K0 | K050506 | 000 |
| D76815428K0 | K050506 | 000 |
| D76815429K0 | K050506 | 000 |
| D76815430K0 | K050506 | 000 |
| D76815431K0 | K050506 | 000 |
| D76815432K0 | K050506 | 000 |
| D76815433K0 | K050506 | 000 |
| D76815235K0 | K050506 | 000 |