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
4,440
Last updated
2026-10-29 05:55:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPA1,5KG / 900ML2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPA60ML2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPA60ML2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPA150ML2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPA150ML2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - 0,9+0,9 KG2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - ORMAPLUS LAB 90 SAMPLE- 0,6KG2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - 2,5+2,5 KG2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - 5+5 KG2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - 4X 5KG2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 90 - 10+10 KG2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 70 - 0,75+0,75 KG2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPALAB 70 - 5+5 KG2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPA1,6KG / 900ML2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPA5KG2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPA10KG2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPA5KG + 2 CAT 60ML2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPA5KG + 2CAT2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPA1,6KG / 900ML2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPA5KG2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPA5KG + 2 CAT 60ML2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPA10KG + 4CAT2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPA5KG2026-10-20
00860012026142DaybreakSleepcare LLCDaybreak Impression Kit2026-10-19
00197998040481Solventum™ Paradigm™Solventum US LLC53112026-10-17
00197998040511Solventum™ Paradigm™Solventum US LLC53152026-10-17
00197998040542Solventum™ Paradigm™Solventum US LLC5313J2026-10-17
00197998040573Solventum™ Paradigm™Solventum US LLC53122026-10-17
00197998040603Solventum™ Paradigm™Solventum US LLC53132026-10-17
00197998040658Solventum™ Paradigm™Solventum US LLC55112026-10-17
00197998040689Solventum™ Paradigm™Solventum US LLC55132026-10-17
00197998040719Solventum™ Paradigm™Solventum US LLC5513J2026-10-17
00197998040764Solventum™ Paradigm™Solventum US LLC55152026-10-17
00850211006021Vaccu-sil VPS Heavy Body 50 Impression MaterialHO DENTAL COMPANY LLCRegular Set2017-10-10
00850211006038Vaccu-sil VPS Heavy Body 50 Impression MaterialHO DENTAL COMPANY LLCFast Set2017-10-10
00850211006045Vaccu-sil VPS Light Body CartridgeHO DENTAL COMPANY LLCFast Set2017-10-10
00850211006052Vaccu-sil VPS Light Body CartridgeHO DENTAL COMPANY LLCRegular Set2017-10-10
00850211006236Vaccu-sil VPS Heavy Body 120 Impression MaterialHO DENTAL COMPANY LLCFast Set2017-10-10
00850211006243Vaccu-sil VPS Heavy Body 120 Impression MaterialHO DENTAL COMPANY LLCRegular Set2017-10-10
00850211006250Vaccu-sil Bite RegistrationHO DENTAL COMPANY LLCRegular Set2017-10-10
00850211006267Vaccu-Sil Mojo Complete Light Body SyringeHO DENTAL COMPANY LLCRegular Set2017-10-10
00850211006274Vaccu-Sil Mojo Complete Light Body SyringeHO DENTAL COMPANY LLCFast Set2017-10-10
08800024200019Vaccusil Heavy BodySherpakoreaVaccusil Heavy Body (50ml * 4 Cartridges)2017-02-10
08800024200026Vaccusil Heavy Body FSSherpakoreaVaccusil Heavy Body FS (50ml * 4 Cartridges)2017-02-10
08800024200033Vaccusil Light BodySherpakoreaVaccusil Light Body (50ml * 4 Cartridges)2017-02-10
08800024200040Vaccusil Light Body FSSherpakoreaVaccusil Light Body FS (50ml * 4 Cartridges)2017-02-10
08800024200057Vaccusil Bite RegistrationSherpakoreaVaccusil Bite Registration (50ml * 2 Cartridges)2017-02-10
08800024200064Mojo CompleteSherpakoreaMojo Complete (2.7ml * 50 Cartridges)2017-02-10
08800024200071Delikit Heavy BodySherpakoreaDelikit Heavy Body (50ml * 2 Cartridges)2017-02-15
08800024200088Delikit Heavy Body FSSherpakoreaDelikit Heavy Body FS (50ml * 2 Cartridges)2017-02-15
08800024200095Delikit Regular BodySherpakoreaDelikit Regular Body (50ml * 2 Cartridges)2017-02-15
08800024200101Delikit Medium BodySherpakoreaDelikit Medium Body (50ml * 2 Cartridges)2017-02-15
08800024200118Delikit Light BodySherpakoreaDelikit Light Body (50ml * 2 Cartridges)2017-02-15
08800024200125Delikit Light Body FSSherpakoreaDelikit Light Body FS (50ml * 2 Cartridges)2017-02-15
08800024200132Delikit Extra Light BodySherpakoreaDelikit Extra Light Body (50ml * 2 Cartridges)2017-02-15
08800024200149Deli Plant Heavy BodySherpakoreaDeli Plant Heavy Body (50ml * 2 Cartridges)2017-02-15
08800024200156Deli Plant Light BodySherpakoreaDeli Plant Light Body (50ml * 2 Cartridges)2017-02-15
08800024200163Deli DentureSherpakoreaDeli Denture (50ml * 2 Cartridges)2017-02-15
08800024200170Delikit Bite RegistrationSherpakoreaDelikit Bite Registration (50ml * 2 Cartridges)2017-02-15
08800024200187Deli MaskSherpakoreaDeli Mask (50ml * 2 Cartridges)2017-02-15
08800024200194Delikit Putty RSSherpakoreaDelikit Putty RS (600ml Set)2017-02-15
08800024200200Delikit Putty FSSherpakoreaDelikit Putty FS (600ml Set)2017-02-15
08800024200217Delikit Jumbo MonophaseSherpakoreaDelikit Jumbo Monophase (360ml * 2 Cartridges)2017-02-15
08800024200224Vaccusil Heavy Body RS 120mlSherpakoreaVaccusil Heavy Body RS 120ml (* 10 Cartridges)2017-02-10
08800024200231Vaccusil Heavy Body FS 120mlSherpakoreaVaccusil Heavy Body FS 120ml (* 10 Cartridges)2017-02-10
08800024200248Precisil Heavy BodySherpakoreaPrecisil Heavy Body (50ml * 2 Cartridges)2017-05-11
08800024200255Precisil Heavy Body FSSherpakoreaPrecisil Heavy Body FS (50ml * 2 Cartridges)2017-05-11
08800024200262Precisil Regular BodySherpakoreaPrecisil Regular Body (50ml * 2 Cartridges)2017-05-11
08800024200279Precisil Medium BodySherpakoreaPrecisil Medium Body (50ml * 2 Cartridges)2017-05-11
08800024200286Precisil Light BodySherpakoreaPrecisil Light Body (50ml * 2 Cartridges)2017-05-11
08800024200293Precisil Light Body FSSherpakoreaPrecisil Light Body FS (50ml * 2 Cartridges)2017-05-11
08800024200309Precisil Extra Light BodySherpakoreaPrecisil Extra Light Body (50ml * 2 Cartridges)2017-05-11
08800024200316Precisil Plant Heavy BodySherpakoreaPrecisil Plant Heavy Body (50ml * 2 Cartridges)2017-05-11
08800024200323Precisil Plant Light BodySherpakoreaPrecisil Plant Light Body (50ml * 2 Cartridges)2017-05-11
08800024200330Precisil DentureSherpakoreaPrecisil Denture (50ml * 2 Cartridges)2017-05-11
08800024200347Precisil Bite RegistrationSherpakoreaPrecisil Bite Registration (50ml * 2 Cartridges2017-05-11
08800024200354Precisil MaskSherpakoreaPrecisil Mask (50ml * 2 Cartridges)2017-05-11
08800024200361Precisil Putty RSSherpakoreaPrecisil Putty RS (600ml Set)2017-05-11
08800024200378Precisil Putty FSSherpakoreaPrecisil Putty FS (600ml Set)2017-05-11
08800024200385Precisil Jumbo MonophaseSherpakoreaPrecisil Jumbo Monophase (360ml * 2 Cartridges)2017-05-11