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510(k) Data Aggregation
K Number
K250833Device Name
SwissMembrane X; SwissMembrane X Socket
Manufacturer
Geistlich Pharma AG
Date Cleared
2025-04-15
(27 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SwissMembrane X is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
SwissMembrane X Socket is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects.
Device Description
SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made of porcine collagen. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membranes are made of collagen without further cross-linking and are sterilized by gamma irradiation.
SwissMembrane X is provided in the following variants and sizes:
- SwissMembrane X D-Line
- 13 x 25 mm (rectangle)
- 25 x 15/25 mm (trapezoid)
- 30 x 25/40 mm (trapezoid)
- SwissMembrane X Socket D-Line
- 14 x 24 mm
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K Number
K233203Device Name
Soft Tissue Augmentation Resorbable Matrix
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-05-01
(216 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.
STAR Matrix is indicated for:
- Covering of implants placed in immediate or delayed extraction sockets;
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
Device Description
The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.
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K Number
K231513Device Name
Oral Matrix
Manufacturer
Beijing Biosis Healing Biological Technology Co., Ltd.
Date Cleared
2024-02-16
(267 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.
Device Description
The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.
The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.
| Model | Size (cm) | Tolerance | Thickness |
|--------------------|-----------|-----------|-------------|
| SIS-ORP-4L-1×1 | 1×1 | | |
| SIS-ORP-4L-2×2 | 2×2 | | |
| SIS-ORP-4L-2×3 | 2×3 | | |
| SIS-ORP-4L-3×3 | 3×3 | | |
| SIS-ORP-4L-4×3 | 4×3 | | |
| SIS-ORP-4L-6×6 | 6×6 | | |
| SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×4 | 4×4 | | |
| SIS-ORP-4L-5×5 | 5×5 | | |
| SIS-ORP-4L-6×8 | 6×8 | | |
| SIS-ORP-4L-8×8 | 8×8 | | |
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K Number
K231305Device Name
Endoform Dental Membrane
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2024-01-23
(263 days)
Product Code
NPL, NPM
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.
Device Description
Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.
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K Number
K230091Device Name
THE Cover
Manufacturer
Purgo Biologics Inc.
Date Cleared
2023-10-06
(267 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE Cover is recommended for:
- Covering of immediate or delayed extraction socket to enhance preservation of the alveolar ridge.
Device Description
THE Cover Resorbable Collagen Membrane is a white, pliable membrane consisting of fibrous collagen matrix purified from porcine tendon. THE Cover act as a barrier between the gingival and the new bone that can facilitate proper bone regeneration. As soft tissues tend to grow faster than the bone can regenerate, the membrane can help protect the bone graft particles from this faster growing connective tissue. As collagen membrane will be dissolved, no additional operation is necessary. THE Cover does not have a distinction between face and back.
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K Number
K223912Device Name
InterCollagen® Guide
Manufacturer
SigmaGraft Inc.
Date Cleared
2023-08-17
(231 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.
- · in the context of a treatment of fenestration defects
- · in case of dehiscence defects
- · after apicoectomy and resection of retained teeth
- · in extraction sockets after tooth extractions
- · in case of immediate or delayed augmentation around implants in extraction sockets
Device Description
InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.
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K Number
K213904Device Name
Kerecis Oral
Manufacturer
Kerecis
Date Cleared
2022-09-30
(290 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
Device Description
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- . 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
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K Number
K212509Device Name
OSSIX Breeze
Manufacturer
Datum Dental Ltd.
Date Cleared
2022-07-18
(343 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:
- 1) Alveolar ridge augmentation and reconstruction,
- 2) Alveolar ridge preservation consequent to tooth extractions,
- 3) Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
- 4) In intra bony defects around teeth,
- 5) Guided tissue regeneration procedures in periodontal defects.
Device Description
OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose. OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
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K Number
K212463Device Name
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
Manufacturer
Geistlich Pharma AG
Date Cleared
2022-04-05
(242 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geistlich Bio-Gide® is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Compressed is indicated for:
- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- guided bone regeneration in dehiscence defects, and
- guided tissue regeneration procedures in periodontal teeth.
Geistlich Bio-Gide® Perio is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects, and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Shape is indicated for:
- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth; and
- guided bone regeneration in dehiscence defects.
Geistlich Combi-Kit Collagen:
Geistlich Bio-Gide® is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge;
- filling of periodontal defects;
- filling of defects after root resection, apicoectomy, and cystectomy;
- filling of extraction sockets to enhance preservation of the alveolar ridge;
- elevation of the maxillary sinus floor;
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR): and
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Perio-System Combi-Pack:
Geistlich Bio-Gide® Perio is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge;
- filling of periodontal defects;
- filling of defects after root resection, apicoectomy, and cystectomy;
- filling of extraction sockets to enhance preservation of the alveolar ridge;
- elevation of the maxillary sinus floor;
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Device Description
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
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K Number
K210280Device Name
Geistlich Mucograft®, Geistlich Mucograft® Seal
Manufacturer
Geistlich Pharma AG
Date Cleared
2021-03-03
(30 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Product Code :
NPL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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
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