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510(k) Data Aggregation
K Number
K193388Device Name
GlassLok Kits, GlassLok Powder, GlassLok Liquid
Manufacturer
Reliance Orthodontic Products Inc.
Date Cleared
2020-04-27
(143 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
Reliance Orthodontic Products Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.
Device Description
GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal).
GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume.
GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization.
Associated accessories include a measuring scoop. Spatula and mixing pad.
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K Number
K161684Device Name
Quantum LB
Manufacturer
Reliance Orthodontic Products Inc.
Date Cleared
2016-10-06
(111 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
Reliance Orthodontic Products Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Device is intended for use as a light cure, orthodontic adhesive.
Device Description
This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.
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