Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
Meta Biomed Co., Ltd.
9478
In Commercial Distribution

  • 08806387894780 ()


  • Dental epoxy resin
ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the amine-containing paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
Meta Biomed Co., Ltd.
9477
In Commercial Distribution

  • 08806387894773 ()


  • Dental epoxy resin
Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok is a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
RELIANCE ORTHODONTIC PRODUCTS INC
NFBL
In Commercial Distribution

  • D798NFBL0 ()
NFBL

  • Dental composite resin
Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok is a unique combination of Resin and Glass Ionomer technology. Band-Lok is Fluoride releasing. Contents of Kit: •(4) 6gm. Syringes of Part A Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
RELIANCE ORTHODONTIC PRODUCTS INC
BL
In Commercial Distribution

  • D798BL0 ()
BL

  • Dental composite resin
Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time. Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands. Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
RELIANCE ORTHODONTIC PRODUCTS INC
NFBLB
In Commercial Distribution

  • D798NFBLB0 ()
NFBLB

  • Dental composite resin
Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time. Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands. Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. Band-Lok is Fluoride releasing. Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
RELIANCE ORTHODONTIC PRODUCTS INC
BLB
In Commercial Distribution

  • D798BLB0 ()
BLB

  • Dental composite resin
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