Glidewell Denture Base Resin— 510(k) K261802

Name: FDA 510(k) clearance K261802
Creator: U.S. Food and Drug Administration
Published: 2026-08-27

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K261802 for Glidewell Denture Base Resin, Substantially Equivalent on 2026-08-27. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2026-06-01
Decision date: 2026-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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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
K260569 — DB 4000 High Impact Denture Base2026-06-02

More clearances from Prismatik Dentalcraft, Inc.

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K262239 — Obsidian® Press Over Zirconia2026-07-30
K254283 — BruxZir® Shaded 16 PLUS2026-01-30
K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems2025-11-18
K252446 — BruxZir® NOW2025-09-03
K250302 — Flexible Partial Resin2025-06-25

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.