FDA.reportPublic FDA data

Dentine bonding agent/set

Definition
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
GUDID devices
4,819
Last updated
2026-09-04 23:10:48

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTD303-22026-06-01
00840456224366JMUJMU DENTAL, INC133010092026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFT768338WW2026-07-22
D798ASK0ASKRELIANCE ORTHODONTIC PRODUCTS INCASK2016-07-25
D798ASKU0ASKRELIANCE ORTHODONTIC PRODUCTS INCASKU2016-07-25
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANY30052502026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANY30052552026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANY30052692026-06-10
00810184450146RodinPac-Dent, Inc.341102-12026-06-10
00195062068508OptiBond Universal 360Kerr Corporation368862024-06-25
00197998024269Solventum™Solventum Germany GmbH419282026-05-08
00197998024276Solventum™Solventum Germany GmbH419252026-05-08
00197998024290Solventum™Solventum Germany GmbH419262026-05-08
00810111540421All-Bond 3BISCO INC.B-36082022-10-12
00810111540445All-Bond UniversalBISCO INC.B-72042022-10-07
00810111540940One-StepBISCO INC.U-11022022-10-07
00810111541930All-Bond 2BISCO INC.B-25112022-10-11
00810111541947All-Bond 2BISCO INC.B-25122022-10-11
00810111541992All-Bond 2BISCO INC.B-25022022-11-17
00810111542418OpaquerBISCO INC.B-21122022-10-11
00810184451754RodinPac-Dent, Inc.341101-12026-05-20
00815967028116RodinPac-Dent, Inc.4711032026-05-20
00815967028123RodinPac-Dent, Inc.4811032026-05-20
00840326403594The Orthodontic StoreYoung Innovations, Inc.J8152022-11-02
00883205045034Peak Universal BondULTRADENT PRODUCTS, INC.45412026-03-28
00883205045041Peak Universal BondULTRADENT PRODUCTS, INC.45422026-03-28
00883205045058Peak Universal BondULTRADENT PRODUCTS, INC.45512026-03-28
00883205045911Peak Universal BondULTRADENT PRODUCTS, INC.S45542026-04-28
00883205045928Peak Universal BondULTRADENT PRODUCTS, INC.S45512026-04-28
040545968117753M™ Scotchbond™3M Deutschland GmbH412952020-10-02
040640351454153M™ Adper™ Prompt™ L-Pop™3M Deutschland GmbH419252024-04-16
040640351454223M™ Adper™ Prompt™ L-Pop™3M Deutschland GmbH419262024-04-16
040640351454393M™ Adper™ Prompt™ L-Pop™3M Deutschland GmbH419282024-04-16
04548162298720BEAUTIBOND XTREMESHOFU DENTAL CORPORATIONY27022023-11-06
06942201728731Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C1-A16(L)2025-05-22
06942201728748Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C1-B322025-05-22
06942201728755Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C1-B402025-05-22
06942201728762Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C1-B40L2025-05-22
06942201728861Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-I82025-05-22
06942201728878Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-I102025-05-22
06942201728885Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-I122025-05-22
06942201728892Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-C142025-05-22
06942201728908Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-C142025-05-22
06942201728915Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-C14L2025-05-22
06942201728922Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-A14(S)2025-05-22
06942201728939Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-A14(L)2025-05-22
06942201728946Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-A16(S)2025-05-22
06942201728953Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-A16(L)2025-05-22
06942201728960Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-B322025-05-22
06942201728977Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-B402025-05-22
06942201728984Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-M-C1-B40L2025-05-22
06942201729080Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-I82025-05-22
06942201729097Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-I102025-05-22
06942201729103Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-I122025-05-22
06942201729110Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-C142025-05-22
06942201729127Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-C142025-05-22
06942201729134Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-C14L2025-05-22
06942201729141Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-A14(S)2025-05-22
06942201729158Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-A14(L)2025-05-22
06942201729165Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-A16(S)2025-05-22
06942201729172Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-A16(L)2025-05-22
06942201729189Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-B322025-05-22
06942201729196Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-B402025-05-22
06942201729202Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-S-C1-B40L2025-05-22
06942201729301Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-I82025-05-22
06942201729318Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-I102025-05-22
06942201729325Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-I122025-05-22
06942201729332Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-C142025-05-22
06942201729349Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-C142025-05-22
06942201729356Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-C14L2025-05-22
06942201729363Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-A14(S)2025-05-22
06942201729370Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-A14(L)2025-05-22
06942201729387Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-A16(S)2025-05-22
06942201729394Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-A16(L)2025-05-22
06942201729400Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-B322025-05-22
06942201729417Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-B402025-05-22
06942201729424Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SHT-M-C1-B40L2025-05-22
06942201729523Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C2-I82025-05-22
06942201729530Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C2-I102025-05-22
06942201729547Tooth Shade Resin MaterialLiaoning Upcera Co.,Ltd.SLT-S-C2-I122025-05-22