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510(k) Data Aggregation
K Number
K100695Device Name
COLLADENTAL BARRIER
Manufacturer
COLLAMATRIX, INC
Date Cleared
2013-01-03
(1029 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
COLLAMATRIX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CollaDental barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.
Device Description
CollaDental Barrier is a nonfriable, resorbable membrane made of purified type I collagen derived from pig skin using standardized controlled manufacturing process. The collagen is obtained from veterinary certified pigs and purified to avoid its antigenicity. The manufacturing process complies with the standards for virus inactivation. The CollaDental Barrier has been tested for purity using standard purity testing procedures, sterlized by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site.
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K Number
K093351Device Name
COLLAWOUND ART
Manufacturer
COLLAMATRIX, INC
Date Cleared
2010-06-16
(232 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
COLLAMATRIX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including:
- partial and full thickness wounds .
- pressure ulcers .
- venous ulcers .
- diabetic ulcers .
- . chronic vascular ulcers
- tunneled/undermined wounds .
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
- draining wounds .
Device Description
CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.
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