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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
SigmaGraft Inc.
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
K221808Device Name
InterOss Collagen
Manufacturer
SigmaGraft Inc.
Date Cleared
2023-03-18
(269 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
SigmaGraft Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:
Filling of extraction sockets to enhance preservation of the alveolar ridge
Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
Device Description
InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.
The product is available in the following shapes and sizes:
| Type | Weight<br>(mg) | Dimension<br>(mm) | Ref# |
|-------|----------------|-------------------|----------|
| Block | 50 | 6 x 6 x 3 | IOC-50 |
| Block | 100 | 6 x 6 x 6 | IOC-100 |
| Block | 250 | 7 x 9 x 8 | IOC-250 |
| Block | 350 | 8 x 10 x 9 | IOC-350 |
| Block | 500 | 10 x 12 x 10 | IOC-500 |
| Plug | 150 | 6 x 10 | IOC-P150 |
| Plug | 250 | 8 x 10 | IOC-P250 |
| Plug | 400 | 11 x 9 | IOC-P400 |
| Plug | 450 | 10 x 12 | IOC-P450 |
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