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510(k) Data Aggregation
K Number
K123697Device Name
MATRICEL DENTAL BARRIER MEMBRANE
Manufacturer
Date Cleared
2014-02-24
(448 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
MATRICEL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for:
- · Ridge augmentation for later implant insertion
- · Augmentation around implants placed in immediate/delayed extraction sockets
- · Localized ridge augmentation
- · Alveolar ridge preservation/reconstruction
- · Osseous fill around implants in peri-implantitis bone defects
- · Over the window in lateral window sinus elevation procedures
- · Intra-bony defects around teeth
- · Treatment of recession defects, together with coronally positioned flap
- · In furcation defects in multi-rooted teeth.
Device Description
The Matricel Dental Barrier Membrane is an intraoral porcine membrane intended to be used in dental applications as a barrier membrane for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) to support the growth of new tissue and bone. The Dental Barrier Membrane is composed of a network of highly purified porcine collagen (predominantly Type I with some Type III) and elastin fibers.
The Dental Barrier Membrane is offered in three sizes (15x20mm, 25x30mm and 30x40mm) with Rough and Smooth surfaces to accommodate physician preferences. The Smooth version is further processed to achieve a flattened surface, whereas the Rough version retains the natural fibrillar structure of the membrane. The Rough and Smooth membrane have identical technological, mechanical and chemical characteristics.
The product is packaged in double blister packs and sterilized by ethylene oxide. The Dental Barrier Membrane is supplied sterile and is indicated for single use.
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