DB 4000 High Impact Denture Base— 510(k) K260569

Name: FDA 510(k) clearance K260569
Creator: U.S. Food and Drug Administration
Published: 2026-06-02

Substantially Equivalent

Carbon, Inc.

FDA 510(k) clearance K260569 for DB 4000 High Impact Denture Base, Substantially Equivalent on 2026-06-02. Applicant: Carbon, Inc.. Device class: 2.

Clearance details

Applicant: Carbon, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2026-02-19
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
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.