FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.

Device Description

BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device called BioCELLECT™-perio, which details its classification, predicate device, and a brief description. The remaining pages are an FDA letter granting substantial equivalence and an "Indications For Use" statement.

Therefore, I cannot extract the requested information.

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K Number

K010775

Device Name

BIOCELLECT

Manufacturer

IMTEC CORP.

Date Cleared

2001-06-12

(90 days)