Address:40 Linville Way,Franklin,IN,46131,US
Device Description : A unique dual cure composite resin cement ideally suited for cementing metal mol A unique dual cure composite resin cement ideally suited for cementing metal molar bands. Chemically bonds to both tooth structure and metal band to create a strong anchor. The glass ionomer technology creates high tensile and compressive strength, reducing washout and loose bands. The cement is ideally mixed and has no strong odor or aftertaste. The adhesive can be light cured to immediately set band in place. Without light activation, a complete set is achieved in five minutes. Contains fluoride for added tooth protection. Easily dispensed from economical screw syringes or in smart automix system.Single 10gm syringe (5gm catalyst & 5gm base).
Device Class : 2
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : 50 replacement syringe tips for M981K-01
Device Class :
Duns Number: 831465641
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel and denin prior to bonding procedures.Kit contains 1x 12gm syringe, disposable mixing tips, and instructions.
Device Class : 2
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bite Bumpers™ work to open deep bite cases by allowing the anteriors to ride up Bite Bumpers™ work to open deep bite cases by allowing the anteriors to ride up and out of occlusion. The Bite Bumpers™ eliminate bond failures of brackets and are especially valuable with ceramic or self-ligating brackets. The unique fixed "placement-jig" guarantees the correct height on the lingual of the tooth an makes sure the two Bite Bumpers™ are 100% parallel. The Bite Bumpers™ are made of a composite polymer that is more comfortable, aesthetic and will increase biocompatibility in nickel sensitive patients. Bite-Bumpers™ are bonded in the same manner as plastic or composite brackets with a slotted mechanical bonding base. Bite Bumper is a registered trademark by Gestenco International AB, Sweden
Device Class : 2
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .022 L1/2 0°T 0°ALucent™ composite brackets feature a nickel-free s LUCENT™ ROTH .022 L1/2 0°T 0°ALucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .018 L1/2 0°T 0°ALucent™ composite brackets feature a nickel-free s LUCENT™ ROTH .018 L1/2 0°T 0°ALucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .022 LL3 -11°T +5°A 2°RLucent™ composite brackets feature a nickel- LUCENT™ ROTH .022 LL3 -11°T +5°A 2°RLucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .022 LL3 HK -11°T +5°ALucent™ composite brackets feature a nickel-f LUCENT™ ROTH .022 LL3 HK -11°T +5°ALucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .022 LR3 -11°T +5°A 2°RLucent™ composite brackets feature a nickel- LUCENT™ ROTH .022 LR3 -11°T +5°A 2°RLucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes
Device Description : LUCENT™ ROTH .022 LR3 HK -11°T +5°ALucent™ composite brackets feature a nickel-f LUCENT™ ROTH .022 LR3 HK -11°T +5°ALucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics.
Device Class :
Duns Number: 831465641
Premarket Exempt : No
Prescription Use : Yes