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510(k) Data Aggregation
K Number
K083480Device Name
INCLUSIVE ZIRCONIA ABUTMENT BLANKS
Manufacturer
INCLUSIVE DENTAL SOLUTIONS
Date Cleared
2009-05-05
(162 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
INCLUSIVE DENTAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inclusive Zirconia Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Inclusive Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. Inclusive Zirconia Abutment Blanks for 3i Implant are compatible with 3i Certain internal hex implants. Inclusive Zirconia Abutment Blanks for Nobel Biocare Implant are compatible with Nobel Biocare Replace straight and tapered internal-connection implants.
Abutments with angulations greater than 20 degrees are contraindicated.
Device Description
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K Number
K083192Device Name
INCLUSIVE TITANIUM ABUTMENT BLANKS
Manufacturer
INCLUSIVE DENTAL SOLUTIONS
Date Cleared
2009-03-04
(126 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
INCLUSIVE DENTAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant.
Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.
Device Description
The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.
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K Number
K073217Device Name
INCLUSIVE IMPLANT ABUTMENTS
Manufacturer
INCLUSIVE DENTAL SOLUTIONS
Date Cleared
2008-05-14
(181 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
INCLUSIVE DENTAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.
Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Device Description
The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.
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