POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM— 510(k) K022912

Name: FDA 510(k) clearance K022912
Creator: U.S. Food and Drug Administration
Published: 2002-09-20

Substantially Equivalent

Basic Dental Implant Systems, Inc.

FDA 510(k) clearance K022912 for POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2002-09-20. Applicant: Basic Dental Implant Systems, Inc.. Device class: 2.

Clearance details

Applicant: Basic Dental Implant Systems, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2002-09-03
Decision date: 2002-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Albuquerque, NM, 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 Basic Dental Implant Systems, Inc.

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K082749 — OMNI-TIGHT2008-12-04
K072595 — OMNI-TIGHT2008-05-09
K013682 — MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM2001-11-28
K012299 — MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM2001-08-01
K001259 — 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM2001-01-12

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.