RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)

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 Syst (5, 5.5,6mm).

Pre-market Notification Details

• Device ID: K944068
• 510k Number: K944068
• Device Name: RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
• 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: 1994-08-15
• Decision Date: 1995-02-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D768L18095001K0	K944068	000
D768R96335006K0	K944068	000
D768RS5008K0	K944068	000
D768RS5010K0	K944068	000
D768RS5010UK0	K944068	000
D768RS5011K0	K944068	000
D768RS5011UK0	K944068	000
D768RS5013K0	K944068	000
D768RS5013UK0	K944068	000
D768RS5015K0	K944068	000
D768R96335004K0	K944068	000
D768R96335002K0	K944068	000
D768L18105001K0	K944068	000
D768L25006000K0	K944068	000
D768L25006001K0	K944068	000
D768L27005000K0	K944068	000
D768L27005001K0	K944068	000
D768R92125548K0	K944068	000
D768R96065002K0	K944068	000
D768R96065004K0	K944068	000
D768R96065006K0	K944068	000
D768RS6008K0	K944068	000
D768RS6010K0	K944068	000
D768R92035048K0	K944068	000
D768R92035062K0	K944068	000
D768R92105001K0	K944068	000
D768R92105002K0	K944068	000
D768R92105003K0	K944068	000
D768R92135501K0	K944068	000
D768R92905002K0	K944068	000
D768R92905004K0	K944068	000
D768R92915002K0	K944068	000
D768R92015548K0	K944068	000
D768R25036002K0	K944068	000
D768RS6011K0	K944068	000
D768RS6013K0	K944068	000
D768RS6015K0	K944068	000
D768L23085004K0	K944068	000
D768L25056002K0	K944068	000
D768L25056003K0	K944068	000
D768L25056004K0	K944068	000
D768L25086000K0	K944068	000
D768L25086001K0	K944068	000
D768R92915004K0	K944068	000