MT-2— 510(k) K961384

Name: FDA 510(k) clearance K961384
Creator: U.S. Food and Drug Administration
Published: 1996-09-25

Substantially Equivalent

The Emerging Technologies Group

FDA 510(k) clearance K961384 for MT-2, Substantially Equivalent on 1996-09-25. Applicant: The Emerging Technologies Group. Device class: 2.

Clearance details

Applicant: The Emerging Technologies Group
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1996-03-19
Decision date: 1996-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Palm Beach, FL, 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 The Emerging Technologies Group

view all

K961381 — KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS1997-09-09
K961382 — MT1A1996-09-25
K961383 — MT11996-09-25
K961385 — MT-3A1996-09-25
K961386 — MT-2A1996-09-25

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.