RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM— 510(k) K954819

Name: FDA 510(k) clearance K954819
Creator: U.S. Food and Drug Administration
Published: 1996-01-11

Substantially Equivalent

Lifecore Biomedical, Inc.

FDA 510(k) clearance K954819 for RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM, Substantially Equivalent on 1996-01-11. Applicant: Lifecore Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Lifecore Biomedical, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1995-10-20
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Lifecore Biomedical, Inc.

view all

K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS2007-11-16
K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM2007-11-09
K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS2007-10-23
K072572 — PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS2007-10-05
K062876 — PRIMACONNEX CERAMIC ABUTMENTS2006-11-01

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.