SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3— 510(k) K953235

Name: FDA 510(k) clearance K953235
Creator: U.S. Food and Drug Administration
Published: 1995-09-13

Substantially Equivalent

The Implant Center of the Palm Beaches

FDA 510(k) clearance K953235 for SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3, Substantially Equivalent on 1995-09-13. 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: 1995-07-11
Decision date: 1995-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Palm Beach, FL, US

Download summary PDF View on FDA.gov ↗

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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
K955048 — KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM1996-01-11

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.