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510(k) Data Aggregation
K Number
K211409Device Name
Proximerge 2 Dental Implant System
Manufacturer
Quadric BioMed, LLC
Date Cleared
2022-10-19
(531 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Quadric BioMed, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.
Device Description
The Proximerge 2TM Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.
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K Number
K041268Device Name
SILVERSITE OR CALGITROL
Manufacturer
ADRI
Date Cleared
2004-09-20
(131 days)
Product Code
MGQ, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Professional Indications (Prescription Use):
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites
Device Description
The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.
The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.
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K Number
K011618Device Name
CALGITROL AG SILVER ALGINATE WOUND DRESSING
Manufacturer
ADRI
Date Cleared
2002-11-15
(539 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites
Device Description
CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin
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K Number
K003134Device Name
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
Manufacturer
ADRI/TECHNAM
Date Cleared
2000-12-22
(77 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADRI/TECHNAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000054Device Name
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
Manufacturer
ADRI
Date Cleared
2000-03-13
(66 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963656Device Name
FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
Manufacturer
ADRI
Date Cleared
1996-11-12
(61 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
ADRI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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