FDA.reportPublic FDA data

Silicone dental impression material

Definition
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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
4,407
Last updated
2026-07-30 21:31:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850004223017Candid Impression KitCANDID CARE CO.IKFINISHED000022019-03-01
00850004223024Candid Impression KitCANDID CARE CO.IKHELLO000012020-07-20
00850004223048Candid Redo Impression KitCANDID CARE CO.RDSMORANGE000012019-03-01
00850004223055Candid Redo Impression KitCANDID CARE CO.RDMDPAT000012019-03-01
00850004223062Candid Redo Impression KitCANDID CARE CO.RDMDORANGE000012019-03-01
00850004223086Candid Redo Impression KitCANDID CARE CO.UBRD00022019-03-01
00850004223093Candid Redo Impression KitCANDID CARE CO.URBD00042019-03-01
00850004223147Candid Redo Impression KitCANDID CARE CO.RDKETTM00012019-10-04
00850004223345Candid Impression KitCANDID CARE CO.FGS-00102021-10-07
00850004223987Candid Refinement Impression KitCANDID CARE CO.ITISK000012021-03-31
00840456219973JMUJMU DENTAL, INC315010032026-07-07
00840456219980JMUJMU DENTAL, INC315010042026-07-07
00840456219997JMUJMU DENTAL, INC315010052026-07-07
00840456220009JMUJMU DENTAL, INC315010062026-07-07
00840456222232JMUJMU DENTAL, INC315010082026-07-07
00840456222249JMUJMU DENTAL, INC315010072026-07-07
00840456222256JMUJMU DENTAL, INC315010092026-07-07
00840456222263JMUJMU DENTAL, INC315010102026-07-07
00840456222270JMUJMU DENTAL, INC315010112026-07-07
00840456222287JMUJMU DENTAL, INC315010122026-07-07
00840456222294JMUJMU DENTAL, INC315010132026-07-07
00840456222300JMUJMU DENTAL, INC315010142026-07-07
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAKRS0102026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAKRS0202026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAKRS0402026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAKRS0442026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAKRS0502026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAKRS0542026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAKRS0602026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAKRS0642026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAKRS0702026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAKRS0742026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAKRS5102026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAKRS5202026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAKRS5402026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAKRS5442026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAKRS5502026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAKRS5542026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAKRS5602026-05-28
18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETLASCOD SPAKRS5642026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETLASCOD SPAKRS5702026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAKRS5742026-05-28
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)LASCOD SPAKRS4002026-05-28
18016200021843KromopanSil Bite 2x50mlLASCOD SPAKRS0952026-05-28
00197998018930Solventum™Solventum Germany GmbH367162026-05-08
00197998018947Solventum™Solventum Germany GmbH367172026-05-08
00304040003251Henry ScheinHENRY SCHEIN, INC.10152082016-09-24
00304040003473Henry ScheinHENRY SCHEIN, INC.10252762016-09-24
00304040003527Henry ScheinHENRY SCHEIN, INC.10268122016-09-24
00304040003565Henry ScheinHENRY SCHEIN, INC.10287522016-09-24
00304040003787Henry ScheinHENRY SCHEIN, INC.11259922016-09-24
00304040003794Henry ScheinHENRY SCHEIN, INC.11259932016-09-24
00304040003855Henry ScheinHENRY SCHEIN, INC.90045962016-09-24
00304040003862Henry ScheinHENRY SCHEIN, INC.90045972016-09-24
00353045001779EnthusDHARMA RESEARCH, INC.38-000012016-10-07
00353045001786EnthusDHARMA RESEARCH, INC.38-000022016-10-07
00353045001793EnthusDHARMA RESEARCH, INC.38-000032016-10-07
00353045001809EnthusDHARMA RESEARCH, INC.38-000042016-10-07
00353045001816EnthusDHARMA RESEARCH, INC.38-000052016-10-07
00353045001823EnthusDHARMA RESEARCH, INC.38-000062016-10-07
00353045001830EnthusDHARMA RESEARCH, INC.38-000072016-10-07
00353045001847EnthusDHARMA RESEARCH, INC.38-000082016-10-07
00353045001854EnthusDHARMA RESEARCH, INC.38-000092016-10-07
00353045001861EnthusDHARMA RESEARCH, INC.38-000102016-10-07
00353045001878EnthusDHARMA RESEARCH, INC.38-000112016-10-07
00353045001885EnthusDHARMA RESEARCH, INC.38-000122016-10-07
00359883001469Affinity™ Crystal VPS 12-PackDEN-MAT HOLDINGS, LLC0109122025-03-12
00359883001537Affinity™ Inflex RS 12-PackDEN-MAT HOLDINGS, LLC0129122025-03-12
00359883001551Affinity™ Inflex FS 12-PackDEN-MAT HOLDINGS, LLC0129522025-03-12
00359883001612Affinity™ Heavy Body RS 12-PackDEN-MAT HOLDINGS, LLC0139122025-03-12
00359883001636Affinity™ Heavy Body FS 12-PackDEN-MAT HOLDINGS, LLC0139522025-03-12
00359883001735Affinity™ Spectrum Quick Bite 12-PackDEN-MAT HOLDINGS, LLC0169122025-03-12
00359883001759Affinity™ Spectrum Quick Bite 36-PackDEN-MAT HOLDINGS, LLC0169362025-03-12
00359883001797Template® Ultra Quick Matrix Material 12-PackDEN-MAT HOLDINGS, LLC0189122025-03-12
00359883001810Template® Ultra Quick Matrix Material 36-PackDEN-MAT HOLDINGS, LLC0189362025-03-12
00359883001834Affinity™ Monophase 12-PackDEN-MAT HOLDINGS, LLC0195402025-03-12
00359883001858Affinity™ Crystal VPS 6-PackDEN-MAT HOLDINGS, LLC0199162025-03-12
00359883001872Affinity™ Crystal VPS 2-PackDEN-MAT HOLDINGS, LLC0214002025-03-12
00359883001896Affinity™ Inflex RS 2-PackDEN-MAT HOLDINGS, LLC0224002025-03-12
00359883001919Affinity™ Inflex Reg Set w/o Tips 2-PackDEN-MAT HOLDINGS, LLC022400W2025-03-12