UltraPrint Flexible Denture UV— 510(k) K261626

Name: FDA 510(k) clearance K261626
Creator: U.S. Food and Drug Administration
Published: 2026-08-13

Substantially Equivalent

Guangzhou Heygears IMC., Inc.

FDA 510(k) clearance K261626 for UltraPrint Flexible Denture UV, Substantially Equivalent on 2026-08-13. Applicant: Guangzhou Heygears IMC., Inc.. Device class: 2.

Clearance details

Applicant: Guangzhou Heygears IMC., Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2026-05-15
Decision date: 2026-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
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 Guangzhou Heygears IMC., Inc.

view all

K253798 — UltraPrint-Dental Hard Splint UV2026-03-02
K253324 — UltraPrint-Dental Denture UV2025-11-20
K213643 — UltraPrint-Dental Temp C&B UV2022-01-14

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.