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510(k) Data Aggregation
K Number
K062733Device Name
TOMAS PIN SD 6, 8, AND 10 MM
Manufacturer
DENTAURUM
Date Cleared
2006-11-09
(57 days)
Product Code
OAT, DZF
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide a fixed anchorage point for attachment of orthodontic appliances.
Device Description
tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin SD is self-drilling. The tomas-pin SD is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.
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K Number
K062732Device Name
TOMAS PIN 6 MM
Manufacturer
DENTAURUM
Date Cleared
2006-10-25
(42 days)
Product Code
OAT, DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide a fixed anchorage point for attachment of orthodontic appliances.
Device Description
Not Found
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K Number
K042965Device Name
TOMAS PIN
Manufacturer
DENTAURUM, INC.
Date Cleared
2005-04-15
(170 days)
Product Code
OAT, DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tomas-pins are temporary, enossal anchorage elements for the treatment of tooth abnormalities in orthodontics and pre-prosthetics.
To provide a fixed anchorage point for attachments of orthodontic appliances.
Temporary Orthodontic Micro Anchorage
Device Description
tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, anchorage elements made or grade 5 thankin (orrroo), according to ASTM (American Society for Testing and Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene.
The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking.
The tomas-pins are available in the following sizes:
Tomas-pin 08 (Order No. 302-008-00)
Length of screw body: 8mm
Diameter: 1.2mm
Tomas-pin 10 (Order No. 302-010-00)
Length of screw body: 10mm
Diameter: 1.2mm
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K Number
K030644Device Name
CONTEC DUO, CONTEC LC, CONTEC LCR
Manufacturer
DENTAURUM
Date Cleared
2003-11-21
(266 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.
Device Description
ConTec Duo, ConTec LC, Contec LCR are adhesive compounds
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K Number
K032195Device Name
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
Manufacturer
DENTAURUM
Date Cleared
2003-10-07
(81 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentaurum GlasTec Dental Orthodontic Cement is a dental glass ionomer cement used to cement orthodontic bands to tooth surfaces.
Device Description
Dentaurum GlasTec Dental Orthodontic Cement
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K Number
K030977Device Name
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
Manufacturer
DENTAURUM
Date Cleared
2003-08-25
(150 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentaurum MIX Two-paste Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
Device Description
Dentaurum MIX Two-paste Bracket Adhesive
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K Number
K030980Device Name
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
Manufacturer
DENTAURUM
Date Cleared
2003-08-25
(150 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentaurum NO-MIX One Step Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
Device Description
Not Found
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K Number
K030641Device Name
CONTEC LIGHT
Manufacturer
DENTAURUM
Date Cleared
2003-06-10
(102 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ConTec Light is used to set resinous dental adhesive material by transmission of visible light.
Device Description
Not Found
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K Number
K011425Device Name
CARMEN
Manufacturer
DENTAURUM, INC.
Date Cleared
2001-06-05
(27 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011428Device Name
TRICERAM
Manufacturer
DENTAURUM, INC.
Date Cleared
2001-06-05
(27 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAURUM, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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