RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)

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 Self Tapping Dental Implant System (3.4mm).

Pre-market Notification Details

• Device ID: K951111
• 510k Number: K951111
• Device Name: RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
• Classification: Implant, Endosseous, Root-form
• Applicant: LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318
• Contact: Lynn Cuperus
• Correspondent: Lynn Cuperus; 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: 1995-03-10
• Decision Date: 1995-03-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D768L18093401K0	K951111	000
D768RS3310K0	K951111	000
D768RS3310UK0	K951111	000
D768RS3311K0	K951111	000
D768RS3311UK0	K951111	000
D768RS3313K0	K951111	000
D768RS3313UK0	K951111	000
D768RS3315K0	K951111	000
D768RS3315UK0	K951111	000
D76841000K0	K951111	000
D76841001K0	K951111	000
D76841002K0	K951111	000
D768RS3308K0	K951111	000
D768R96553406K0	K951111	000
D768R96553402K0	K951111	000
D768L18103401K0	K951111	000
D768L23014200K0	K951111	000
D768L23014201K0	K951111	000
D768R280000K0	K951111	000
D768R921240K0	K951111	000
D768R96333402K0	K951111	000
D768R96333404K0	K951111	000
D768R96333406K0	K951111	000
D768R96423402K0	K951111	000
D768R96423404K0	K951111	000
D768R96423406K0	K951111	000
D76841003K0	K951111	000
D76841005K0	K951111	000
D76841006K0	K951111	000
D768R92014048K0	K951111	000
D768R92033448K0	K951111	000
D768R92134001K0	K951111	000
D768R92903402K0	K951111	000
D768R92903404K0	K951111	000
D768R92913402K0	K951111	000
D768R92913404K0	K951111	000
D768R93013448K0	K951111	000
D768R93024048K0	K951111	000
D768R93035048K0	K951111	000
D768R93044048K0	K951111	000
D768R92004048K0	K951111	000
D768R23024202K0	K951111	000
D768L23083404K0	K951111	000
D76841007K0	K951111	000
D7684102403402K0	K951111	000
D7684102403404K0	K951111	000
D768L23003301K0	K951111	000
D768L23003302K0	K951111	000
D768L23003303K0	K951111	000
D768L23044202K0	K951111	000
D768L23044203K0	K951111	000
D768L23044204K0	K951111	000
D768L23074200K0	K951111	000
D768L23074201K0	K951111	000
D768R93054048K0	K951111	000