NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)— 510(k) K993595

Name: FDA 510(k) clearance K993595
Creator: U.S. Food and Drug Administration
Published: 2000-01-28

Substantially Equivalent

Nobel Biocare Uas, Inc.

FDA 510(k) clearance K993595 for NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT), Substantially Equivalent on 2000-01-28. Applicant: Nobel Biocare Uas, Inc.. Device class: 2.

Clearance details

Applicant: Nobel Biocare Uas, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1999-10-25
Decision date: 2000-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, 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 Nobel Biocare Uas, Inc.

view all

K050444 — NOBELREPLACE ADAPTER, MODEL 324122005-07-07
K042658 — PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-60042004-10-20
K041661 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS2004-08-26
K041876 — NOBELDIRECT OD IMPLANT2004-08-20
K041312 — NOBELRONDO DENTAL CERAMIC-ALUMINA2004-07-23

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.