DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET— 510(k) K970572

Name: FDA 510(k) clearance K970572
Creator: U.S. Food and Drug Administration
Published: 1998-01-16

Substantially Equivalent

Implant Integration Systems, Inc.

FDA 510(k) clearance K970572 for DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET, Substantially Equivalent on 1998-01-16. Applicant: Implant Integration Systems, Inc.. Device class: 2.

Clearance details

Applicant: Implant Integration Systems, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1997-02-14
Decision date: 1998-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paradise, CA, US

Download summary PDF View on FDA.gov ↗

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K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Implant Integration Systems, Inc.

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K962610 — DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES1996-10-18
K962394 — IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS1996-10-11
K944225 — DUAL INTEGRATOR DENTAL IMPLANT1995-09-27

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.