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510(k) Data Aggregation
K Number
K982400Device Name
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
Manufacturer
STERI-OSS, INC.
Date Cleared
1998-09-23
(75 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.
Device Description
Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.
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K Number
K980439Device Name
REPLACE CYLINDRICAL IMPLANTS
Manufacturer
STERI-OSS, INC.
Date Cleared
1998-03-16
(40 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for these devices is to serve as support for prosthetic devices to restore patient chewing function.
Device Description
The Steri-Oss Replace Cylindrical Implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). The implant is designed to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial dentition and the prosthetic device is designed to serve as the crown. The implants are 3.25, 4.3, 5.0 or 6.0 mm in diameter and from 10 - 16 mm in length and are composed of titanium. They are tapered, cylindrical and have a hexed head. The implants may be non-coated or coated (HA or TPS). The Replace Cylindrical Implants utilize color coding.
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K Number
K973423Device Name
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-12-05
(86 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
Device Description
This device is designed to serve as support for prosthetic devices to restore patient chewing function. This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium alloy. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed hydroxyapatite coating, and the surface of the external hex is anodized magenta in color.
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K Number
K973433Device Name
STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-12-05
(86 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
Device Description
Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium allov. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed titanium powder coating, and the surface of the external hex is anodized magenta in color.
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K Number
K973402Device Name
STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-11-26
(78 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for this device system is to serve as support for prosthetic devices to restore patient chewing functions.
Device Description
Individual components fulfill the following purposes:
Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
Steri-Oss 3.25 mm Replace Healing Screw: This device is designed to protect the internal threads of the implant during healing.
Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.
Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.
The implants are 3.25 mm in diameter, are 10 to 16 mm in length, and are fabricated from titanium alloy. They are tapered, threaded, and have a superior external hex. The healing screw, healing abutment, and abutment are also fabricated from titanium alloy. Portions of the surface of each of the components are anodized magenta in color.
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K Number
K972965Device Name
STERI-OSS UNTIL IMPLANT CEMENT
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-11-07
(88 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
Steri-Oss Until . Implant Cement is indicated_ for .... cementing (luting) of a implant prosthesis.
Device Description
The Steri-Oss Until Implant Cement serves as a cement for retention of armund on mixing cement serves as a cement roll - that is self cured on mixing The cement is a cwo pars pars provided in two 10 gram containers of polyalkylene material.
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K Number
K970073Device Name
BIO-ESTHETIC INDIRECT ABUTMENT
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-07-03
(176 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.
Device Description
How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.
Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.
Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.
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K Number
K964739Device Name
STERI-OSS TIODIZED SCREW
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-03-31
(125 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.
Device Description
Attachment of prosthetic components to one another and to implants can be achieved with screw fasteming systems. The attachment is secured by the application of torque to the screw. Screws used to fasten the prosthetic components can sometimes loosen. The greater the preload that is applied. the less chance there is that the screw will eventually become loose. Titanium screws that have been "tiodized" can be preloaded to a much greater torque than untreated prosthetic component screws and thus are less likely to loosen. Tiodized® screws are manufactured in diameters (across the head) ranging from 0.086 to 0.106 inches and lengths ranging from 0.160 to 0.576 inches and are composed of titanium alloy that has been subjected to a proprietary anodization process. The screws are slotted or are internally or externally hexed for acceptance of driving tools such as screw drivers, hex drivers and wrenches. Tiodized screws are provided sterile, and are packaged either individually or in sets of up to 6 screws. Tiodized® screws may also be packaged with dental implants or dental implant prosthetic components.
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K Number
K964220Device Name
REPLACE TITANIUM IMPLANT SYSTEM
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-03-05
(134 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
Device Description
The Steri-Oss Replace Titanium Implant System is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 4.3, 5.0 or 6.0 mm in diameter, from 10 - 16 mm in length and are composed of titanium. They are tapered, threaded and have a hexed superior surface. The Replace Titanium Implant System utilizes color coding.
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K Number
K963945Device Name
STERI-OSS GOLD ATTACHMENT SYSTEM
Manufacturer
STERI-OSS, INC.
Date Cleared
1997-02-11
(132 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERI-OSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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