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510(k) Data Aggregation
K Number
K150128Device Name
GC Ortho Connect, GC Ortho Etching Gel
Manufacturer
Date Cleared
2015-07-16
(177 days)
Product Code
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
GC Orthodontics America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GC Ortho Connect
- 1. Bonding metal brackets and attachments
- 2. Bonding ceramic brackets
- 3. Bonding plastic brackets and acrylic appliances
GC Ortho Etching Gel
- 1. Etching enamel of tooth surfaces
- 2. Enhancing the bond strength of light-cured orthodontic adhesive materials
Device Description
Not Found
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K Number
K143667Device Name
GC KommonBase
Manufacturer
Date Cleared
2015-05-07
(135 days)
Product Code
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
GC Orthodontics America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabricating resin base (understructure) for bracket placement
Device Description
Not Found
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