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Found 4 results
510(k) Data Aggregation
K Number
K122069Device Name
STORM MINI SCREW
Manufacturer
LANCER ORTHODONTICS, INC.
Date Cleared
2013-04-11
(269 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
LANCER ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
Device Description
The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed to be immediately used as an anchorage for orthodontic devices. The Storm mini-screw head is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
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K Number
K071192Device Name
BLUGOO HD
Manufacturer
LANCER ORTHODONTICS, INC.
Date Cleared
2007-06-22
(53 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
LANCER ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
Device Description
Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.
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K Number
K051552Device Name
O.A.S.I. SYSTEM
Manufacturer
LANCER ORTHODONTICS, INC.
Date Cleared
2005-09-19
(98 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
LANCER ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is intended for use in patients where orthodontic treatment has been completed. Screws are intended for single use only.
Device Description
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
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K Number
K991481Device Name
PARAGON
Manufacturer
LANCER ORTHODONTICS, INC.
Date Cleared
1999-08-11
(105 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
LANCER ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
paragon, a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.
Device Description
a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.
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