FDA.reportPublic FDA data

Polyether dental impression material

Definition
An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
GUDID devices
358
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035077000352Permadyne™3M Deutschland GmbH307502017-08-04
04035077000383Ramitec™3M Deutschland GmbH330202017-08-04
04035077000390Ramitec™3M Deutschland GmbH330502017-08-04
04035077001618Impregum™ F3M Deutschland GmbH317122017-08-04
04035077001625Permadyne™3M Deutschland GmbH307112017-08-04
04035077002134Permadyne™3M Deutschland GmbH307102017-08-04
04035077003377Impregum™ Penta™ Soft Quick Step Heavy Body3M Deutschland GmbH317692017-08-04
04035077003421Impregum™ Penta™3M Deutschland GmbH316422017-08-04
04035077003445Impregum™ Penta™ Soft Heavy Body3M Deutschland GmbH317412017-08-04
04035077003476Impregum™ Penta™ Soft Light Body3M Deutschland GmbH317462017-08-04
04035077003490Impregum™ Penta™ Soft Medium Body3M Deutschland GmbH317312017-08-04
04035077003537Impregum™ Penta™ Soft Quick Step Medium Body3M Deutschland GmbH317652017-08-04
04035077003636Permadyne™ Penta™ L3M Deutschland GmbH303122017-08-04
04035077003667Permadyne™ Penta™ H3M Deutschland GmbH301032017-08-04
04035077003742Ramitec™ Penta™3M Deutschland GmbH331122017-08-04
04035077005500Impregum™ F3M Deutschland GmbH314742017-08-04
04035077005517Impregum™ F3M Deutschland GmbH315042017-08-04
04035077005531Impregum™ Garant™ Soft Light Body3M Deutschland GmbH317522017-08-04
04035077010085Impregum™ Penta™ Soft Medium Body3M Deutschland GmbH317312017-08-04
04035077013000Permadyne™3M Deutschland GmbH307512017-08-04
04035077036559Impregum™ Super Quick3M Deutschland GmbH693792018-06-04
04035077036566Impregum™ Penta™ Super Quick3M Deutschland GmbH693852018-06-04
040545967359103M™ Impregum™3M Deutschland GmbHP317792026-05-08
10386040004800COE-FLEX®Gc America Inc.1310022022-07-07
10386040004817COE-FLEX®Gc America Inc.1310032022-07-07
10386040004824COE-FLEX®Gc America Inc.1310042022-07-07
10386040004831COE-FLEX®Gc America Inc.1310052022-07-07
10386040004848COE-FLEX®Gc America Inc.1311022022-07-07
10386040004855COE-FLEX®Gc America Inc.1311032022-07-07
10386040004862COE-FLEX®Gc America Inc.1311042022-07-07
10386040004879COE-FLEX®Gc America Inc.1311052022-07-07
10386040005500OMNIFLEX™Gc America Inc.1373012022-07-07
10815878020275Burkhart VPS Heavy Body 50mL (4)BURKHART DENTAL SUPPLY CO., THE727206062016-09-16
10815878020282Burkhart VPS Heavy Body Fast Set 50mL (4)BURKHART DENTAL SUPPLY CO., THE727206052016-09-16
10815878020299Burkhart VPS Light Body 50mL(4)BURKHART DENTAL SUPPLY CO., THE727206012016-09-16
10815878020305Burkhart VPS Light Body Fast Set 50mL (4)BURKHART DENTAL SUPPLY CO., THE727206072016-09-16
10815878020312Burkhart VPS Monophase 50mL(4)BURKHART DENTAL SUPPLY CO., THE727206042016-09-16
10815878020329Burkhart VPS Regular Body 50mL (4)BURKHART DENTAL SUPPLY CO., THE727206032016-09-16
10815878020336Burkhart VPS Regular Body Fast Set 50mL (4)BURKHART DENTAL SUPPLY CO., THE727206022016-09-16
D0470084821EXACLEARGc America Inc.0084822016-08-01
D6581310021COE-FLEX®Gc America Inc.1310022016-08-01
D6581310031COE-FLEX®Gc America Inc.1310032016-08-01
D6581310041COE-FLEX®Gc America Inc.1310042016-08-01
D6581310051COE-FLEX®Gc America Inc.1310052016-08-01
D6581311021COE-FLEX®Gc America Inc.1311022016-08-01
D6581311031COE-FLEX®Gc America Inc.1311032016-08-01
D6581311041COE-FLEX®Gc America Inc.1311042016-08-01
D6581311051COE-FLEX®Gc America Inc.1311052016-08-01
D6581373011OMNIFLEX™Gc America Inc.1373012016-08-01
D724D0103600Vivid Elegance VSP Light RS PEARSON DENTAL SUPPLIES, INC.D0103602016-06-23
D724D0103620Vivid Elegance VSP Light RSPEARSON DENTAL SUPPLIES, INC.D0103622016-06-23
D724D0103640Vivid Elegance VSP Light FSPEARSON DENTAL SUPPLIES, INC.D0103642016-06-23
D724D0103660Vivid Elegance VSP Light FSPEARSON DENTAL SUPPLIES, INC.D0103662016-06-23
D724D0105021Vivid Elegance VSP Light Regular SetPEARSON DENTAL SUPPLIES, INC.D0105022017-06-07
D724D0105041Vivid Elegance VSP Light FSPEARSON DENTAL SUPPLIES, INC.D0105042017-06-07
D724D0105061Vivid Elegance VSP Medium Regular setPEARSON DENTAL SUPPLIES, INC.D0105062017-06-07
D724D0105081Vivid Elegance VSP Medium Fast setPEARSON DENTAL SUPPLIES, INC.D0105082017-06-07
D724D0105101Vivid Elegance VSP Mono Regular SetPEARSON DENTAL SUPPLIES, INC.D0105102017-06-07
D724D0105121Vivid Elegance VSP Mono Fast SetPEARSON DENTAL SUPPLIES, INC.D0105122017-06-07
D724D0105141Vivid Elegance VSP Heavy Regular SetPEARSON DENTAL SUPPLIES, INC.D0105142017-06-07
D724D0105161Vivid Elegance VSP Heavy Fast SetPEARSON DENTAL SUPPLIES, INC.D0105162017-06-07
D724D0105181Vivid Elegance VSP Light Regular SetPEARSON DENTAL SUPPLIES, INC.D0105182017-06-07
D724D0105201Vivid Elegance VSP Light Fast SetPEARSON DENTAL SUPPLIES, INC.D0105202017-06-07
J001702011027800Permadyne™3M Deutschland GmbH307512016-09-24
J001702011063850Permadyne™3M Deutschland GmbH307502016-09-24
J001702011066250Ramitec™3M Deutschland GmbH330202016-09-24
J001702011066330Ramitec™3M Deutschland GmbH330502016-09-24
J001702011128050Impregum™ F3M Deutschland GmbH317122016-09-24
J001702011128470Permadyne™3M Deutschland GmbH307112016-09-24
J001702011128620Permadyne™ Garant™ 2:13M Deutschland GmbH304132016-09-24
J001702011159640Permadyne™3M Deutschland GmbH307102016-09-24
J001702011248260Impregum™ Penta™ Soft Quick Step Heavy Body3M Deutschland GmbH317692016-09-24
J001702011248830Impregum™ Penta™3M Deutschland GmbH316422016-09-24
J001702011249090Impregum™ Penta™ Soft Heavy Body3M Deutschland GmbH317412016-09-24
J001702011249330Impregum™ Penta™ Soft Light Body3M Deutschland GmbH317462016-09-24
J001702011249580Impregum™ Penta™ Soft Medium Body3M Deutschland GmbH317312016-09-24
J001702011300470Impregum™ Penta™ Soft Quick Step Medium Body3M Deutschland GmbH317652016-09-24
J001702011301790Permadyne™ Penta™ L3M Deutschland GmbH303122016-09-24
J001702011302030Permadyne™ Penta™ H3M Deutschland GmbH301032016-09-24
J001702011302860Ramitec™ Penta™3M Deutschland GmbH331122016-09-24