FDA.reportPublic FDA data

Dental prosthesis priming agent

Definition
A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.
GUDID devices
77
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810111540070Z-Prime PlusBISCO INC.B-6003S2022-10-10
00810111540117Porcelain PrimerBISCO INC.B-22212022-09-30
00889813020647Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190632018-08-31
00889813020661Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190642018-08-31
00889813020678Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190662018-08-31
00889813020692Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190672018-08-31
00889813020715Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190682018-08-31
07615208406146SR LinkIVOCLAR VIVADENT AKTIENGESELLSCHAFT5458722023-03-20
10818207020113Best EtchVista Dental5021152018-08-06
10818207020120Best EtchVista Dental5022352018-08-06
10818207020137Best EtchVista Dental5022302018-08-06
10818207020144Best EtchVista Dental5022002018-08-06
10818207020151Best EtchVista Dental5022252018-08-06
10818207020168Porcelain EtchVista Dental5025002018-07-31
10818207020175Porcelain EtchVista Dental5025102018-07-31
10818207020182Porcelain EtchVista Dental5025122018-07-31
10818207020199SilaneVista Dental5025052018-07-31
D745701198PVC00041Glidewell Zirconia PrimerPrismatik Dentalcraft, Inc70-1198-PVC00042022-07-19
D757B2224P0Porcelain Primer 1.5ml SmplBISCO INC.B-2224P2017-06-12
EBRE540012850DTK adhesive opakbredent GmbH & Co. KG540012852023-09-05
EBRE540012950DTK adhesive opakbredent GmbH & Co. KG540012952023-09-05
MPBEK1Mirage Prolong Bond Enhancer KitCHAMELEON DENTAL PRODUCTS, INCPBEK2018-10-26
MPBERA1Mirage Prolong Silane Bond Enhancer ACHAMELEON DENTAL PRODUCTS, INCPBERA2019-02-21
MPBERB1MIRAGE PROLONG SILANE BOND ENHANCER BCHAMELEON DENTAL PRODUCTS, INCPBERB2019-02-21
MSBE11Mirage Silane Bond EnhancerCHAMELEON DENTAL PRODUCTS, INCSBE2020-01-20
07290115051889Smile Stream STEP-1 PumEtchB.J.M. LABORATORIES LTD9000-10002026-03-13
06972220484325Ceramic Coupling AgentRizhao HuGe Biomaterials Company, Ltd.5ml2024-12-09
07290115050448Porcelain FixB.J.M. LABORATORIES LTD4000842023-11-22
07290115050462Porcelain SilaneB.J.M. LABORATORIES LTD4000832023-11-22
07290115050479Porcelain EtchB.J.M. LABORATORIES LTD4000822023-11-22
00348783000627Premier Universal PrimerPREMIER DENTAL PRODUCTS COMPANY30015682020-02-25
00348783000634Premier Universal PrimerPREMIER DENTAL PRODUCTS COMPANY30015692020-02-25
EBRE540012859DTK adhesive opakbredent GmbH & Co. KG540012852023-09-05
EBRE540012959DTK adhesive opakbredent GmbH & Co. KG540012952023-09-05
EDEL13700200DELTABONDDeltaMed GmbH13700202023-06-29
EDEL6021160Insure® SilanatorDeltaMed GmbH6021162023-06-12
EDEL13513500ACRIFIXDeltaMed GmbH13513502023-05-12
03760260223119Silan-ITITENA CLINICALSILAN-IT2022-10-18
00810111540124Porcelain PrimerBISCO INC.B-2223P2022-10-11
10810111540077Z-Prime PlusBISCO INC.B-6003S2022-10-10
10810111540114Porcelain PrimerBISCO INC.B-22212022-09-30
04260635981372PRO Resins Denture BondDeltaMed GmbH019.33312022-09-23
00810111540063Z-Prime PlusBISCO INC.B-60022022-08-02
00810111542432Porcelain Bonding ResinBISCO INC.B-31102022-08-02
10810111540060Z-Prime PlusBISCO INC.B-6002P2022-08-02
00810111540100Bis-SilaneBISCO INC.B-3210P2022-08-01
10810111540053Z-Prime PlusBISCO INC.B-6001P2022-08-01
00810111540056Z-Prime PlusBISCO INC.B-60012022-07-29
00810111540087Bis-SilaneBISCO INC.B-32112022-07-29
00810111540094Bis-SilaneBISCO INC.B-32122022-07-29
D745701198PVC00020Glidewell Zirconia PrimerPrismatik Dentalcraft, Inc70-1198-PVC00022022-07-19
D745701198PVC00040Glidewell Zirconia PrimerJames R. Glidewell, Dental Ceramics, Inc.70-1198-PVC00042022-07-19
D757B31100Porcelain Bonding ResinBISCO INC.B-31102017-06-12
D757B3110P1Porcelain Bonding ResinBISCO INC.B-3110P2017-06-12
D757B22210Porcelain PrimerBISCO INC.B-22212022-05-18
D757B6003S0Z-Prime PlusBISCO INC.B-6003S2022-05-17
D757B2221P1Porcelain PrimerBISCO INC.B-2221P2017-06-12
D757B2223P0Porcelain PrimerBISCO INC.B-2223P2017-06-12
D757B3210P1Bis-SilaneBISCO INC.B-3210P2017-06-12
D757B32110Bis-SilaneBISCO INC.B-32112017-06-12
D757B32120Bis-SilaneBISCO INC.B-32122017-06-12
D757B60010Z-Prime PlusBISCO INC.B-60012017-06-12
D757B6001P1Z-Prime PlusBISCO INC.B-6001P2017-06-12
D757B60020Z-Prime PlusBISCO INC.B-60022017-06-12
D757B6002P1Z-Prime PlusBISCO INC.B-6002P2017-06-12
D757B6003PS1Z-Prime PlusBISCO INC.B-6003PS2017-06-12
EDEL160695003Delta Denture BondDeltaMed GmbH16069502022-02-11
E235Y00050HC PRIMERSHOFU DENTAL CORPORATIONY00052021-02-03
D757B3003PS1FluoroCalBISCO INC.B-3003PS2017-06-12
EKUR000061KA1CLEARFIL™ PORCELAIN BOND ACTIVATORKURARAY NORITAKE DENTAL INC.#061-KA2017-02-17
EKUR000064KA1ALLOY PRIMERKURARAY NORITAKE DENTAL INC.#064-KA2017-02-17
EKUR003637KA1CLEARFIL™ CERAMIC PRIMER PLUSKURARAY NORITAKE DENTAL INC.#3637-KA2017-02-17
EKUR003638KA1CLEARFIL™ CERAMIC PRIMER PLUSKURARAY NORITAKE DENTAL INC.#3638-KA2017-02-17
E217135811Visalys Restorative PrimerKettenbach GmbH & Co. KG135812019-11-25
00850194007893Omni Etch Ceramic Etch and SilaneVista Dental12019-12-13
00850194007138Vista Zirconia Primer 2ml SyringeVista Dental12016-06-16
00850194007152Vista Zirconia Primer 4ml BottleVista Dental12016-06-16