The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for The Lifecore Stage-1 Single Stage Rbm Dental Implant System.
| Device ID | K003226 |
| 510k Number | K003226 |
| Device Name: | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Carolyn Anderson |
| Correspondent | Carolyn Anderson LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-16 |
| Decision Date | 2001-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768RSW48142K0 | K003226 | 000 |
| D768RSR48103K0 | K003226 | 000 |
| D768RSR48102K0 | K003226 | 000 |
| D768RSR48083K0 | K003226 | 000 |
| D768RSR48082K0 | K003226 | 000 |
| D768RSR41163K0 | K003226 | 000 |
| D768RSR41162K0 | K003226 | 000 |
| D768RSR41143K0 | K003226 | 000 |
| D768RSR41142K0 | K003226 | 000 |
| D768RSR48122K0 | K003226 | 000 |
| D768RSR48123K0 | K003226 | 000 |
| D768RSR48142K0 | K003226 | 000 |
| D768RSW48123K0 | K003226 | 000 |
| D768RSW48122K0 | K003226 | 000 |
| D768RSW48103K0 | K003226 | 000 |
| D768RSW48102K0 | K003226 | 000 |
| D768RSW48083K0 | K003226 | 000 |
| D768RSW48082K0 | K003226 | 000 |
| D768RSR48162K0 | K003226 | 000 |
| D768RSR48143K0 | K003226 | 000 |
| D768RSR41123K0 | K003226 | 000 |
| D768RSR41122K0 | K003226 | 000 |
| D768RSR41103K0 | K003226 | 000 |
| D76842026K0 | K003226 | 000 |
| D76842025K0 | K003226 | 000 |
| D76842024K0 | K003226 | 000 |
| D76842023K0 | K003226 | 000 |
| D76842022K0 | K003226 | 000 |
| D76842021K0 | K003226 | 000 |
| D76842012K0 | K003226 | 000 |
| D76842011K0 | K003226 | 000 |
| D768RSR33082K0 | K003226 | 000 |
| D768RSR33083K0 | K003226 | 000 |
| D768RSR33102K0 | K003226 | 000 |
| D768RSR41102K0 | K003226 | 000 |
| D768RSR41083K0 | K003226 | 000 |
| D768RSR41082K0 | K003226 | 000 |
| D768RSR33143K0 | K003226 | 000 |
| D768RSR33142K0 | K003226 | 000 |
| D768RSR33123K0 | K003226 | 000 |
| D768RSR33122K0 | K003226 | 000 |
| D768RSR33103K0 | K003226 | 000 |
| D76842005K0 | K003226 | 000 |
| D768S2504K0 | K003226 | 000 |
| D768S240500K0 | K003226 | 000 |
| D768S2400K0 | K003226 | 000 |
| D76842020K0 | K003226 | 000 |
| D76842019K0 | K003226 | 000 |
| D76842018K0 | K003226 | 000 |
| D76842017K0 | K003226 | 000 |
| D76842014K0 | K003226 | 000 |
| D76842008K0 | K003226 | 000 |
| D768S240501K0 | K003226 | 000 |
| D768S2408K0 | K003226 | 000 |
| D768S24170K0 | K003226 | 000 |
| D768S2501701K0 | K003226 | 000 |
| D768S2501551K0 | K003226 | 000 |
| D768S2501401K0 | K003226 | 000 |
| D768S2435K0 | K003226 | 000 |
| D768S2432701K0 | K003226 | 000 |
| D768S2432551K0 | K003226 | 000 |
| D768S2432401K0 | K003226 | 000 |
| D768S24172K0 | K003226 | 000 |
| D76842007K0 | K003226 | 000 |
| D76842004K0 | K003226 | 000 |
| D768S2506K0 | K003226 | 000 |
| D768RSW63102K0 | K003226 | 000 |
| D768RSW63082K0 | K003226 | 000 |
| D768RSW55142K0 | K003226 | 000 |
| D768RSW55123K0 | K003226 | 000 |
| D768RSW55122K0 | K003226 | 000 |
| D768RSW55103K0 | K003226 | 000 |
| D768RSW55102K0 | K003226 | 000 |
| D768RSW55083K0 | K003226 | 000 |
| D768S1800000 | K003226 | 000 |
| D768S180000K0 | K003226 | 000 |
| D768S180015K0 | K003226 | 000 |
| D768S243570K0 | K003226 | 000 |
| D768S240701K0 | K003226 | 000 |
| D768S240700K0 | K003226 | 000 |
| D768S2401K0 | K003226 | 000 |
| D768S180645K0 | K003226 | 000 |
| D768S180630K0 | K003226 | 000 |
| D768S180045K0 | K003226 | 000 |
| D768S180030K0 | K003226 | 000 |
| D768RSW55082K0 | K003226 | 000 |