Glidewell Denture Base Resin— 510(k) K261802
Substantially EquivalentPrismatik 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.
Summary
Prismatik Dentalcraft filed Glidewell Denture Base Resin under product code EBI, resin for denture relining, repairing, or rebasing. The record gives no model numbers.
Class II, 21 CFR 872.3760. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).
Prismatik filed from Irvine, California. The substantially equivalent decision came 87 calendar days after receipt (June 1 to August 27, 2026).
Clearance details
- Applicant
- Prismatik Dentalcraft, 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
- Irvine, CA, US
Recent devices under product code EBI
view allMore clearances from Prismatik Dentalcraft, 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.