Denture Base Resin V2— 510(k) K262300
Substantially EquivalentFormlabs 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.
Summary
Formlabs Ohio's Denture Base Resin V2 is filed under EBI, denture relining, repairing, and rebasing resins. The record doesn't give the resin's composition.
Class II, 21 CFR 872.3760. Dental is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).
Formlabs filed from Millbury, Ohio. The decision came 1 calendar day after FDA received it (July 7 to July 8, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Formlabs Ohio, 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
- Abbreviated
- Location
- Millbury, OH, US
Recent devices under product code EBI
view allMore clearances from Formlabs Ohio, 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.