ENDOBON XENOGRAFT GRANULES— 510(k) K110449

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K110449 for ENDOBON XENOGRAFT GRANULES, Substantially Equivalent on 2011-05-13. Applicant: Biomet 3i. Device class: 2.

Clearance details

Applicant: Biomet 3i
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2011-02-16
Decision date: 2011-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110449

K-number listed on FDA's recall record

Z-0788-2016 — Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.Class II·Terminated·Biomet France SARL·20160121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110449.

Data sourced from openFDA. This site is unofficial and independent of the FDA.