Denture Base Resin V2— 510(k) K262300

Name: FDA 510(k) clearance K262300
Creator: U.S. Food and Drug Administration
Published: 2026-07-08

Substantially Equivalent

Formlabs Ohio, Inc.

FDA 510(k) clearance K262300 for Denture Base Resin V2, Substantially Equivalent on 2026-07-08. Applicant: Formlabs Ohio, Inc.. Device class: 2.

Clearance details

Applicant: Formlabs Ohio, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2026-07-07
Decision date: 2026-07-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Millbury, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K261474 — DENTCA Tru Flexible2026-07-01
K260569 — DB 4000 High Impact Denture Base2026-06-02

More clearances from Formlabs Ohio, Inc.

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K240538 — Premium Teeth Resin2024-07-19
K232087 — Dental LT Comfort Resin2024-02-16
K222061 — Dental LT Clear V2 Resin2022-11-10

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.