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510(k) Data Aggregation
K Number
K130618Device Name
SFI-ANCHOR
Manufacturer
CENDRES & METAUX SA
Date Cleared
2014-03-03
(361 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
Device Description
The SFI-Anchor® D20 is an endosseous dental implant abutment for the fixation of (dental) prostheses to the following ITI Dental Implant System® / Straumann® Dental Implant Systems: Standard Ø 4.1 mm Regular Neck (RN) / Standard Ø 4.8 mm Regular Neck (RN) / Standard Plus Ø 4.1 mm Regular Neck (RN) / Standard Plus Ø 4.8 mm Regular Neck (RN) / Tapered Effect Ø 4.1 mm Regular Neck (RN) / Bone Level Ø 4.1 mm, Regular CrossFit® (RC) / Bone Level Ø 4.8 mm, Regular CrossFit® (RC). The SFI-Anchor® CD 20 is intended as an additional retaining element on dental bars. The SFI-Anchor® D20 are straight abutments with gingival heights ranging from 1mm to 5 mm. The SFI-Anchor® CD 20 is a straight bar attachment. The SFI-Anchor® Housing and the SFI-Anchor® Retention Inserts can correct for up to 10° of divergence (20° of divergence between two implants). The SFI-Anchor® is offered in a diameter 4.8 mm. The SFI-Anchor® D20 is connected to the corresponding implants via a mating screw thread and interface geometry. The SFI-Anchor® CD20 is directly screwed on a dental bar construct. The SFI-Anchor® Housing is cemented in the dental prostheses. The SFI-Anchor® Housing, along with an SFI-Anchor® Retention Insert, allow connection of the prosthesis to the abutment / bar attachment by retention-grip. The abutments / bar attachment are machined from Titanium Alloy conforming to ASTM F-136. Other SFI-Anchor® key functional parts are made out of Elitor® (conforming to standard ISO 22674) and of Pekkton® conforming to standard ASTM D3418, ASTM D638 and ASTM D790.
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K Number
K131526Device Name
SFI-BAR
Manufacturer
CENDRES & METAUX SA
Date Cleared
2013-09-23
(118 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.
Device Description
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar@ consists of an implant adapter (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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K Number
K123638Device Name
PEKKTON IVORY
Manufacturer
CENDRES & METAUX SA
Date Cleared
2013-02-21
(87 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.
Device Description
Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.
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K Number
K111390Device Name
SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
Manufacturer
CENDRES & METAUX SA
Date Cleared
2011-09-12
(117 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.
Device Description
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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K Number
K102382Device Name
SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
Manufacturer
CENDRES & METAUX SA
Date Cleared
2010-12-03
(102 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.
Device Description
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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K Number
K083876Device Name
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
Manufacturer
CENDRES & METAUX SA
Date Cleared
2010-02-26
(424 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**CENDRES **& METAUX SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.
The SFI Bar consists of the following variants:
SFI-Bar® 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region
SFI-Bar® 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region
Device Description
Not Found
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