CYTOPLAST REGENTEX TITANIUM 250— 510(k) K972278

Name: FDA 510(k) clearance K972278
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Osteogenics Co.

FDA 510(k) clearance K972278 for CYTOPLAST REGENTEX TITANIUM 250, Substantially Equivalent on 1997-08-06. Applicant: Osteogenics Co.. Device class: 2.

Clearance details

Applicant: Osteogenics Co.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1997-06-18
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K972278

K-number listed on FDA's recall record

Z-0113-2017 — Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.Class II·Terminated·Osteogenics Biomedical, Inc.·20160907

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972278.

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