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Found 3 results
510(k) Data Aggregation
K Number
K110926Device Name
BONE PLATE; BONE SCREW
Manufacturer
BIOMATERIALS KOREA INC.
Date Cleared
2011-12-08
(251 days)
Product Code
JEY, DZL
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
BIOMATERIALS KOREA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a) The Bone Plates are indicated for orofacial (maxilla or mandible) fracture or damage.
b) The Bone Screws are indicated for the fixation of the Bone Plate.
Device Description
Bone Plate; Bone Screw
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K Number
K111809Device Name
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
Manufacturer
BIOMATERIALS KOREA INC.
Date Cleared
2011-09-26
(91 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMATERIALS KOREA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SL Type and SPL Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.
Device Description
Not Found
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K Number
K063495Device Name
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
Manufacturer
BIOMATERIALS KOREA INC.
Date Cleared
2007-07-26
(248 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMATERIALS KOREA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C Type, CT Type and Special Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.
Device Description
Not Found
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