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FDA 510(k)

NanoCeram Resin

K-Number: K262681 · 2026-07-31

Applicant3BFAB TEKNOLOJI A.S.
Decision Date2026-07-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NanoCeram Resin is the device name listed in this FDA 510(k) record. The listed applicant is 3BFAB TEKNOLOJI A.S.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K262681. 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 NanoCeram Resin?

NanoCeram Resin is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is 3BFAB TEKNOLOJI A.S.. The 510(k) number is K262681.

When did NanoCeram Resin receive FDA 510(k) clearance?

NanoCeram Resin received FDA 510(k) clearance on 2026-07-31, under 510(k) number K262681.

Who is the listed applicant for NanoCeram Resin?

The FDA 510(k) record lists 3BFAB TEKNOLOJI A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoCeram Resin?

The FDA product code for NanoCeram Resin is EBI.

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.

K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material CorporationK253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)Graphy, Inc.

Official Source

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

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