UltraPrint Flexible Denture UV— 510(k) K261626
Substantially EquivalentGuangzhou 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.
Summary
Guangzhou Heygears IMC. filed UltraPrint Flexible Denture UV under product code EBI, resin for denture relining, repairing, or rebasing. No model numbers are listed.
Class II, 21 CFR 872.3760. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Heygears filed from Guangzhou, China. The substantially equivalent decision came 90 calendar days after receipt (May 15 to August 13, 2026).
Clearance details
- Applicant
- Guangzhou Heygears IMC., Inc.
- Product code
- Product code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code EBI
view allMore clearances from Guangzhou Heygears IMC., Inc.
view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.