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Found 6 results
510(k) Data Aggregation
K Number
K230305Device Name
THE Graft Collagen
Manufacturer
Purgo Biologics Inc.
Date Cleared
2024-07-24
(537 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE Graft Collagen is recommended for:
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
Device Description
THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
Block (Height x Length x Width)
3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.
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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?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
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
K222549Device Name
OpenTex
Manufacturer
Purgo Biologics Inc.
Date Cleared
2023-05-11
(261 days)
Product Code
NPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
Device Description
OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.
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K Number
K191737Device Name
The Graft Bone Substitute
Manufacturer
Purgo Biologics Inc.
Date Cleared
2020-02-14
(231 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
Device Description
THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA).
THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in vial or syringe. It is produced by removal of all organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorganic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is favored due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency.
THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.
THE Graft Bone Substitute is not intended to be marketed or sold with multiple components and/or accessories.
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K Number
K180992Device Name
Biotex
Manufacturer
Purgo Biologics Inc.
Date Cleared
2019-07-16
(456 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.
Device Description
Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.
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K Number
K173188Device Name
The Graft Natural Bone Substitute
Manufacturer
Purgo Biologics Inc.
Date Cleared
2018-07-20
(291 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Purgo Biologics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
Device Description
THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA). THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency. THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.
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