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510(k) Data Aggregation
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
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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