JET SET 4 DENTURE REPAIR RESIN— 510(k) K152981

Name: FDA 510(k) clearance K152981
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Substantially Equivalent

Lang Dental Manufacturing Company, Inc.

FDA 510(k) clearance K152981 for JET SET 4 DENTURE REPAIR RESIN, Substantially Equivalent on 2016-09-02. Applicant: Lang Dental Manufacturing Company, Inc.. Device class: 2.

Clearance details

Applicant: Lang Dental Manufacturing Company, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2015-10-09
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.