KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM— 510(k) K955048

Name: FDA 510(k) clearance K955048
Creator: U.S. Food and Drug Administration
Published: 1996-01-11

Substantially Equivalent

The Implant Center of the Palm Beaches

FDA 510(k) clearance K955048 for KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM, Substantially Equivalent on 1996-01-11. Applicant: The Implant Center of the Palm Beaches. Device class: 2.

Clearance details

Applicant: The Implant Center of the Palm Beaches
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1995-11-03
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Palm Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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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 The Implant Center of the Palm Beaches

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K974280 — ABUTMENT - COMPLETE1998-02-20
K960111 — KIS MT41996-03-27
K960110 — KIS MT31996-03-20
K960112 — KIS MT51996-03-15
K953558 — KIS II LG HEX SCREW & CYLINDER IMPLANTS1995-12-19

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.