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510(k) Data Aggregation
K Number
K034022Device Name
UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
Manufacturer
Date Cleared
2004-01-30
(32 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIAMODENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutments. The abutments will seat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders.
All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG),
| IMPLANT COMPANIES | IMPLANT SYSTEMS | IMPLANT SIZE (mm) |
|--------------------|--------------------------------|-----------------------------------------------------|
| Nobel Biocare | NobelPerfect<br>Replace Select | 3.5, 4.3 & 5.0mm<br>3.5, 4.3, 5.0 & 6.0mm |
| Straumann | ITI | 3.5mm Shoulder Diameter<br>Narrow Neck Solid Screw |
| | ITI | 4.8mm Shoulder Diameter<br>Solid Screw |
| | ITI | 6.5mm Shoulder Diameter<br>Wide Neck Solid Screw |
| Dentsply/ Friadent | Frialit-2<br>XIVE | 3.4, 3.8, 4.5, 5.5 & 6.5mm<br>3.4, 3.8, 4.5 & 5.5mm |
| 3i | Osscotite Certain | 4.0, 5.0 & 6.0mm |
Device Description
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K Number
K010619Device Name
UCLA AND UNIVERSAL ABUTMENTS
Manufacturer
Date Cleared
2001-09-28
(211 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIAMODENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993129Device Name
UCLA/UNIVERSAL ABUTMENT
Manufacturer
Date Cleared
2000-03-28
(190 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIAMODENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- . Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw.
- Impression Posts are used to register the location and position of the implants in mouth.
- Implant Analogs are replicas of the implants and are mounted in stone model.
- . Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement.
- Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement.
- Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting.
All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.
Device Description
UCLA/Universal Abutments, Impression Posts, Implant Analogs, Cement Retained Abutments, Temporary Abutments, Tools, and Accessories.
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