RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS

Implant, Endosseous, Root-form

LIFECORE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Restore, Stage-1, Renova Primasolo And Primaconnex Dental Implants.

Pre-market Notification Details

• Device ID: K072768
• 510k Number: K072768
• Device Name: RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
• Classification: Implant, Endosseous, Root-form
• 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: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-28
• Decision Date: 2007-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D76842003K0	K072768	000
D768S11012016K0	K072768	000
D768S11012810K0	K072768	000
D768S11012816K0	K072768	000
D768S11013510K0	K072768	000
D768S11013516K0	K072768	000
D768S11014210K0	K072768	000
D768S11014216K0	K072768	000
D768S11014810K0	K072768	000
D768S11014816K0	K072768	000
D768S11015510K0	K072768	000
D768S140001K0	K072768	000
D768S140002K0	K072768	000
D768S140003K0	K072768	000
D768S11012010K0	K072768	000
D768S11005510K0	K072768	000
D768S11004816K0	K072768	000
D768ISS140K0	K072768	000
D768ISS141K0	K072768	000
D768S11001610K0	K072768	000
D768S11001616K0	K072768	000
D768S11002010K0	K072768	000
D768S11002016K0	K072768	000
D768S11002810K0	K072768	000
D768S11002816K0	K072768	000
D768S11003510K0	K072768	000
D768S11003516K0	K072768	000
D768S11004210K0	K072768	000
D768S11004216K0	K072768	000
D768S11004810K0	K072768	000
D768S14013301K0	K072768	000
D768S140201K0	K072768	000
D768S180335K0	K072768	000
D768S180342K0	K072768	000
D768S180348K0	K072768	000
D768S180355K0	K072768	000
D768S1805K0	K072768	000
D768S2418131K0	K072768	000
D768S2418191K0	K072768	000
D768S24191K0	K072768	000
D768S24201K0	K072768	000
D768S242613K0	K072768	000
D768S242619K0	K072768	000
D768S2427K0	K072768	000
D768S2428K0	K072768	000
D768S180328K0	K072768	000
D768S1802K0	K072768	000
D768S170103K0	K072768	000
D768S15003310K0	K072768	000
D768S15003316K0	K072768	000
D768S15005510K0	K072768	000
D768S15005516K0	K072768	000
D768S15006310K0	K072768	000
D768S15014110K0	K072768	000
D768S15014116K0	K072768	000
D768S15014810K0	K072768	000
D768S15014816K0	K072768	000
D768S160101K0	K072768	000
D768S1700K0	K072768	000
D768S170101K0	K072768	000
D768S170102K0	K072768	000
D768S2503K0	K072768	000