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FDA 510(k)

Denture Base Resin V2

K-Number: K262300 · 2026-07-08

ApplicantFormlabs Ohio, Inc.
Decision Date2026-07-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Denture Base Resin V2 is the device name listed in this FDA 510(k) record. The listed applicant is Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K262300. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Denture Base Resin V2?

Denture Base Resin V2 is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K262300.

When did Denture Base Resin V2 receive FDA 510(k) clearance?

Denture Base Resin V2 received FDA 510(k) clearance on 2026-07-08, under 510(k) number K262300.

Who is the listed applicant for Denture Base Resin V2?

The FDA 510(k) record lists Formlabs Ohio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denture Base Resin V2?

The FDA product code for Denture Base Resin V2 is EBI.

Other records listing Formlabs Ohio, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240538Premium Teeth ResinK232087Dental LT Comfort ResinK222061Dental LT Clear V2 Resin

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material CorporationK253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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