ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT— 510(k) K895267

Name: FDA 510(k) clearance K895267
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Artech Corp.

FDA 510(k) clearance K895267 for ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT, Substantially Equivalent on 1990-04-10. 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: 1989-08-23
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

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K894160 — HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL1989-09-28
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.