FDA.report

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
273
Last updated
2026-01-21 14:52:22

Related Product Codes

CodeDeviceSpecialtyClassDevices
ELWMaterial, ImpressionDental2264
EIDSyringe, Restorative And Impression MaterialDental17
EBHMaterial, Impression Tray, ResinDental11
EBIResin, Denture, Relining, Repairing, RebasingDental21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
D6581310022COE-FLEX®Gc America Inc.1310022016-08-01
D6581310032COE-FLEX®Gc America Inc.1310032016-08-01
D6581310042COE-FLEX®Gc America Inc.1310042016-08-01
D6581310052COE-FLEX®Gc America Inc.1310052016-08-01
D6581311022COE-FLEX®Gc America Inc.1311022016-08-01
D6581311032COE-FLEX®Gc America Inc.1311032016-08-01
D6581311042COE-FLEX®Gc America Inc.1311042016-08-01
D6581311052COE-FLEX®Gc America Inc.1311052016-08-01
D6581312021COE-FLEX®Gc America Inc.1312022016-08-01
D6581312031COE-FLEX®Gc America Inc.1312032016-08-01
D6581312041COE-FLEX®Gc America Inc.1312042016-08-01
D6581312051COE-FLEX®Gc America Inc.1312052016-08-01
D6581313021COE-FLEX®Gc America Inc.1313022016-08-01
D6581313031COE-FLEX®Gc America Inc.1313032016-08-01
D6581313041COE-FLEX®Gc America Inc.1313042016-08-01
D6581313051COE-FLEX®Gc America Inc.1313052016-08-01
D6581324121EXABITE™Gc America Inc.1324122016-08-01
D6581324181EXABITE™Gc America Inc.1324182016-08-01
D6581373012OMNIFLEX™Gc America Inc.1373012016-08-01
D6581373111OMNIFLEX™Gc America Inc.1373112016-08-01
D6581373211OMNIFLEX™Gc America Inc.1373212016-08-01
D6581373361OMNIFLEX™Gc America Inc.1373362016-08-01
J014660993170FlexitimeKulzer GmbH660993172025-06-10
J014660993180FlexitimeKulzer GmbH660993182025-06-10
J014660993190FlexitimeKulzer GmbH660993192025-06-10
J014660993200FlexitimeKulzer GmbH660993202025-06-10
J014660993210FlexitimeKulzer GmbH660993212025-06-10
J014661004810FlexitimeKulzer GmbH661004812025-06-10
J014400043530DYNAMIX MIXING TIPS (1 X 50)Kulzer GmbH400043532016-10-21
J014660675142Xantasil Fast Set Bulk Pack 50X50mlKulzer GmbH660675142017-02-27
J014500354060PROVIL NOVO L. 1X280 MLHeraeus Kulzer GmbH500354062024-09-09
J014500354120PROVIL NOVO P SOFT FAST 1X500Heraeus Kulzer GmbH500354122024-09-09
J014657670380CUTTERSIL P PLUS 1X900 MLHeraeus Kulzer GmbH657670382024-09-09
J014658179300CUTTERSIL LIGHT GREEN 1X140 MLHeraeus Kulzer GmbH658179302024-09-09
J014660036390FLEXITIME HEAVY TRAY 1 X 50 ML SAMPLEHeraeus Kulzer GmbH660036392024-09-09
J014660036400FLEXITIME MONO PHASE 1 X 50 ML SAMPLEHeraeus Kulzer GmbH660036402024-09-09
J014660036410FLEXITIME CORRECT FLOW 1 X 50 ML SAMPLEHeraeus Kulzer GmbH660036412024-09-09
J014660082900PROVIL NOVO L. F CD2 1X(2X50ML)Heraeus Kulzer GmbH660082902024-09-09
J014660082910PROVIL NOVO MED. F CD2 1X(2X50ML)Heraeus Kulzer GmbH660082912024-09-09
J014660082920PROVIL NOVO MED. R CD2 1X(2X50ML)Heraeus Kulzer GmbH660082922024-09-09
J014660082930PROVIL NOVO MONO F CD 2 1X(2X50ML)Heraeus Kulzer GmbH660082932024-09-09
J014660082940PROVIL NOVO MONO R CD2 1X(2X50ML)Heraeus Kulzer GmbH660082942024-09-09
J014660410630FLEXITIME HEAVY TRAY & FLOW TRIAL KITHeraeus Kulzer GmbH660410632024-09-09
J014660410650FLEXITIME DYNAMIX PUTTY & FLOW TRIAL KITHeraeus Kulzer GmbH660410652024-09-09
J014660457930FLEXITIME FAST&SCAN DYN. HT & FLOW TRIALHeraeus Kulzer GmbH660457932024-09-09
J014660464580PROVIL NOVO MONO 1X280 MLHeraeus Kulzer GmbH660464582024-09-09
J014660464710PROVIL NOVO L. R CD2 1X(2X50ML)Heraeus Kulzer GmbH660464712024-09-09
J014660464720PROVIL NOVO P SOFT FAST 1X900Heraeus Kulzer GmbH660464722024-09-09
J014660464730PROVIL NOVO P FAST 1X900mlHeraeus Kulzer GmbH660464732024-09-09
J014660464740PROVIL NOVO P REG 1X900Heraeus Kulzer GmbH660464742024-09-09
J014660471780PROVIL NOVO DYNAMIX PUTTY REF(1X2X380ml)Heraeus Kulzer GmbH660471782024-09-09
J014660472030PROVIL NOVO P SOFT REG 1 x 900mlHeraeus Kulzer GmbH660472032024-09-09
J014660773770FLEXITIME LIGHT FLOW 1X50ML SAMPLEHeraeus Kulzer GmbH660773772024-09-09
J014660773780FLEXITIME MEDIUM FLOW 1X50ML SAMPLEHeraeus Kulzer GmbH660773782024-09-09
J014600359990DYNAMIX MIXING TIPS (1 X 50)Heraeus Kulzer GmbH600359992016-09-23
J014660196820FLEXITIME XTREME STARTER KITHeraeus Kulzer GmbH660196822016-09-15
J014660196840FLEXITIME XTREME HEAVY TRAY REF.12X50 MLHeraeus Kulzer GmbH660196842016-09-15
J014660196850FLEXITIME XTREME HEAVY TRAY REF. 6X50 MLHeraeus Kulzer GmbH660196852016-09-15
J014660196870FLEXITIME XTREME CORRECT FL. REF.12X50MLHeraeus Kulzer GmbH660196872016-09-15
J014660196880FLEXITIME XTREME CORRECT FL. REF. 6X50MLHeraeus Kulzer GmbH660196882016-09-15
J014660196890FLEXITIME XTREME CORRECT FL.SAMPLE1X50MLHeraeus Kulzer GmbH660196892016-09-15
00810052610306Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218402024-01-15
00810052610313Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218412024-01-15
00810052610320Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218422024-01-15
00810052610337Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218432024-01-15
00810052610696Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218442024-01-15
00810052611013Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218452024-01-15
00810052611020Burkhart Dental SupplyBURKHART DENTAL SUPPLY CO., THE727218462024-01-15
J014400039900FLEXITIME DYNAMIX MONO REFILL(1X2X380ml)Heraeus Kulzer GmbH400039902016-10-21
J014400039910FLEXITIME DYNAMIX HT REFILL 1X(2X380ml)Heraeus Kulzer GmbH400039912016-10-21
J014400039920FLEXITIME DYNAMIX PUTTY REFILL1X(2X380mlHeraeus Kulzer GmbH400039922016-10-21
J014400050400FLEXITIME LIGHT FLOW 1 X (2 X 50 ML)Heraeus Kulzer GmbH400050402016-10-21
J014400050410FLEXITIME MEDIUM FLOW 1 X (2 X 50 ML)Heraeus Kulzer GmbH400050412016-10-21
J014500348020FLEXITIME EASY PUTTY 1 X 600 MLHeraeus Kulzer GmbH500348022016-10-21
J014500348040FLEXITIME HEAVY TRAY 1X(2 X 50 ML)Heraeus Kulzer GmbH500348042016-10-21
J014500348060FLEXITIME CORRECT FLOW 1 X (2 X 50 ML)Heraeus Kulzer GmbH500348062016-10-21
J014500348110FLEXITIME MONO PHASE 1 X (2 X 50 ML)Heraeus Kulzer GmbH500348112016-10-21
J014500350180MEMOSIL 2 1 X (2 X 50 ML)Heraeus Kulzer GmbH500350182016-09-23
J014500354070PROVIL NOVO MED. 1X280 MLHeraeus Kulzer GmbH500354072016-09-15
J014500354110PROVIL NOVO P SOFT REG 1X500Heraeus Kulzer GmbH500354112016-09-15