Search Results
Found 1 results
510(k) Data Aggregation
(127 days)
Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:
- covering of implants placed in immediate or delayed extraction sockets;
- localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
- alveolar ridge reconstruction for prosthetic treatment; and
- recession defects for root coverage.
Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants
- Alveolar ridge reconstruction for prosthetic treatment
- Recession defects for root coverage
Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.
The products are provided as follows:
- Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm
- Geistlich Mucograft® Seal: 8 mm and 12 mm diameter
Geistlich Fibro-Gide® is a fully resorbable, porous, collagen matrix of porcine origin of a spongious consistency. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The collagen scaffold is weakly crosslinked. Geistlich Fibro-Gide® is sterilized in double packaging by Gamma-irradiation.
Geistlich Fibro-Gide® is an implantable device intended for use in soft tissue augmentation procedures. As described in more detail below, the device is indicated specifically for insufficient tissue volume at the alveolar ridge and for soft tissue recession. It has mechanical properties appropriate to withstand the mechanical stresses that occur after wound closure in soft tissue augmentation procedures, i.e., it has good volume stability and it withstands early resorption to allow the formation of new soft tissue and degrades over time. In addition, the matrix is designed with an appropriate thickness to provide sufficient space for the ingrowth of new soft tissue. Due to its good wettability, suturability and biological properties, the device becomes well integrated into the surrounding soft tissue.
The products are provided as follows:
- 15 x 20 x 6 mm
- 20 x 40 x 6 mm
- 15 x 20 x 3 mm
- 20 x 40 x 3 mm
N/A
Ask a specific question about this device
Page 1 of 1