HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL— 510(k) K894160

Name: FDA 510(k) clearance K894160
Creator: U.S. Food and Drug Administration
Published: 1989-09-28

Substantially Equivalent

Artech Corp.

FDA 510(k) clearance K894160 for HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL, Substantially Equivalent on 1989-09-28. Applicant: Artech Corp.. Device class: 2.

Clearance details

Applicant: Artech Corp.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1989-06-14
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, 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 Artech Corp.

view all

K911735 — ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT1992-03-05
K895267 — ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT1990-04-10
K891346 — ARTECH TYPE SS SUBMERGED SCREW IMPLANT1989-12-21
K894150 — COUNTERBORE FOR SS SUBMERGED SCREW PLANT1989-09-27
K894151 — IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT1989-09-27

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.