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510(k) Data Aggregation

    K Number
    K103020
    Device Name
    ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2011-02-03

    (114 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region only.
    Device Description
    The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
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    K Number
    K073540
    Device Name
    ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2008-02-29

    (73 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for BioHorizons Implant and abutment screws are made from biocompatible vttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.
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    K Number
    K073258
    Device Name
    ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2008-02-14

    (86 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for BioHorizons Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons
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    K Number
    K072483
    Device Name
    ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-11-16

    (73 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for 3i Certain MicroMini Implant is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.
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    K Number
    K071946
    Device Name
    ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-10-05

    (84 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.
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    K Number
    K070833
    Device Name
    ATLANTIS ABUTMENT FOR ASTRA IMPLANT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-06-22

    (87 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed™ 3.5(S) mm, 4.0(S) mm Internal Hex Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for Astra Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.5 S mm, 4.0 S mm OsseoSpeed™ Implants.
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    K Number
    K063734
    Device Name
    ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-03-02

    (74 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for 3i Certain Interface is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards (6972 & 13356). The abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Osseotite NT® Certain™ Implants (tapered wall) with 4.0 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) diameters.
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    K Number
    K062197
    Device Name
    ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-02-28

    (211 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for 3i Certain MicroMini Implant is compatible with 3i Osseotite NT® Certain and Parallel Walled Implants both with 3.25 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 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 fixture.
    Device Description
    The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 3i Certain™ MicroMini Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Osseotite NT® Certain™ and Parallel Walled Implants both with a 3.25mm diameter.
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    K Number
    K062069
    Device Name
    ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2007-02-14

    (208 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic reconstruction in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: Mk III 3.3mm, Threaded HL Series 3.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.
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    K Number
    K062277
    Device Name
    ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    2006-12-20

    (135 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATLANTIS COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Zimmer Dental, 3i, Lifecore, Sterngold, Innova and BioHorizons. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 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 devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Nobel Replace is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screw is made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.
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