FDA.reportPublic FDA data

Dental acrylic resin kit

Definition
A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes acrylic resin material (without hardening fillers/materials) and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prostheses. After application, this device cannot be reused.
GUDID devices
27
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840326403549The Orthodontic StoreYoung Innovations, Inc.J04982022-11-02
00840326403563The Orthodontic StoreYoung Innovations, Inc.J801K2022-11-02
00840326403570The Orthodontic StoreYoung Innovations, Inc.J804K2022-11-02
D161210010AxioBond 5Axiodent Inc.21001 Intro Pack2024-10-02
D161210020AxioBond 5Axiodent Inc.21002 Economy Pack2024-10-02
D161210030AxioBond 7Axiodent Inc.21003 Intro Pack2024-10-02
D161210040AxioBond 7Axiodent Inc.21004 Economy Pack2024-10-02
D161210050AxioBond DCAxiodent Inc.21005 5ml2024-10-02
D161210060AxioBond MDPAxiodent Inc.21006 Regular Pack2024-10-02
D161210070AxioBond UniversalAxiodent Inc.21007 Intro Pack2024-10-02
D161210080AxioBond UniversalAxiodent Inc.21008 Regular Pack2024-10-02
D161210090AxioBond UniversalAxiodent Inc.21009 2x5ml2024-10-02
D96710001Fusion Bond 7 PREVEST DENPRO LIMITEDIntro Pack2024-04-23
D96710002Fusion Bond 7 PREVEST DENPRO LIMITEDEconomy Pack2024-04-23
D96710003Fusion Bond 5PREVEST DENPRO LIMITEDIntro Pack2024-04-23
D96710004Fusion Bond 5 PREVEST DENPRO LIMITEDEconomy Pack2024-04-23
D96710005Fusion Bond DCPREVEST DENPRO LIMITEDIntro Pack2024-04-23
D96710016Renew MDPPREVEST DENPRO LIMITEDRegular Pack2024-04-23
D96710017Renew UniversalPREVEST DENPRO LIMITEDIntro Pack2024-04-23
D96710018Renew UniversalPREVEST DENPRO LIMITEDRegular Pack2024-04-23
D96710019Renew UniversalPREVEST DENPRO LIMITEDEconomy Pack2024-04-23
10840326403546The Orthodontic StoreYoung Innovations, Inc.J04982022-11-02
10840326403560The Orthodontic StoreYoung Innovations, Inc.J801K2022-11-02
10840326403577The Orthodontic StoreYoung Innovations, Inc.J804K2022-11-02
00842092112328GingivamollPreat Corporation09000032022-10-25
00842092112335GingivamollPreat Corporation09000042022-10-25
00842092155820GingivamollPreat Corporation09000012022-10-25