NanoCeram Resin— 510(k) K262681

Name: FDA 510(k) clearance K262681
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

3BFAB TEKNOLOJI A.S.

FDA 510(k) clearance K262681 for NanoCeram Resin, Substantially Equivalent on 2026-07-31. Applicant: 3BFAB TEKNOLOJI A.S.. Device class: 2.

Summary

NanoCeram Resin from 3BFAB Teknoloji is filed under EBI, denture relining, repairing, and rebasing resins. The record doesn't give its composition.

Class II, 21 CFR 872.3760. Dental is both the classification panel and the review panel. It was a Traditional 510(k).

3BFAB filed from Istanbul, Turkey. The decision came 1 calendar day after receipt (July 30 to July 31, 2026). The record flags it as a third-party review.

Clearance details

Applicant: 3BFAB TEKNOLOJI A.S.
Product code: Product code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2026-07-30
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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K261626 — UltraPrint Flexible Denture UV2026-08-13
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01
K260569 — DB 4000 High Impact Denture Base2026-06-02

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.