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510(k) Data Aggregation
K Number
K120338Device Name
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
Manufacturer
ASTRA TECH INC.
Date Cleared
2012-07-05
(153 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ASTRA TECH 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, screw retained or friction fit 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 Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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 on small diameter implants are intended for the anterior region of the mouth only.
Device Description
The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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 angulated abutments on small implants are to be used for the anterior region of the mouth only.
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 for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
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K Number
K113003Device Name
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
Manufacturer
ASTRA TECH INC.
Date Cleared
2012-03-01
(146 days)
Product Code
NHA, CLA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ASTRA TECH 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 endentulous 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 and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 of the mouth 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 titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized 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
K093483Device Name
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT
Manufacturer
ASTRA TECH INC.
Date Cleared
2009-12-22
(43 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ASTRA TECH 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:
The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes
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™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
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