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FDA 510(k)

DENTCA Tru Flexible

K-Number: K261474 · 2026-07-01

ApplicantDentca, Inc.
Decision Date2026-07-01
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTCA Tru Flexible is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261474. 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 DENTCA Tru Flexible?

DENTCA Tru Flexible is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Dentca, Inc.. The 510(k) number is K261474.

When did DENTCA Tru Flexible receive FDA 510(k) clearance?

DENTCA Tru Flexible received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261474.

Who is the listed applicant for DENTCA Tru Flexible?

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

What is the FDA product code for DENTCA Tru Flexible?

The FDA product code for DENTCA Tru Flexible is EBI.

Other records listing Dentca, 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.

K220042Dentca Base Premium, Dentca Base Hi-ImpactK192806DENTCA Crown and BridgeK172398DENTCA DENTURE TeethK162044Dentca Denture Base II

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.K262300Denture Base Resin V2Formlabs Ohio, 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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