ALVEOGRAF DURAPATITE(18-40 MESH)— 510(k) K813257

Name: FDA 510(k) clearance K813257
Creator: U.S. Food and Drug Administration
Published: 1982-01-05

Substantially Equivalent

Sterling Drug, Inc.

FDA 510(k) clearance K813257 for ALVEOGRAF DURAPATITE(18-40 MESH), Substantially Equivalent on 1982-01-05. Applicant: Sterling Drug, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Drug, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1981-11-19
Decision date: 1982-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Sterling Drug, Inc.

view all

K901369 — GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II1990-06-05
K896110 — BIOBRANE(R) II1989-11-28
K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER1988-01-27
K840260 — PERIOGRAF DURAPATITE 40-60 MESH1984-04-05
K820023 — CONAGRAF TM DURAPATITE CONES1982-02-24

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.