FDA.report

Precisil Regular Body Biggg

Primary DI
08800024201382
Brand
Precisil Regular Body Biggg
Company
Sherpakorea
Model
Precisil Regular Body Biggg (75ml * 25 Cartridges)
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800024201382PrimaryGS10

GMDN Terms

TermDefinition
Silicone dental impression materialAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+827078429961happidenco@naver.com

Regulatory Flags

DUNS number
557822311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800024201986Implant Heavy BodyImplant Heavy Body (50ml Cartridge)2023-08-03
08800024205946Implant MonophaseImplant Monophase (50ml Cartridge)2023-08-03
08800024206011Implant Light BodyImplant Light Body (50ml Cartridge)2023-08-03
08800024206318Deli-Bite Clear Deli-Bite Clear (50ml*4cartridges)2023-06-28
08800024206295Delikit Extra Light Body FastDelikit Extra Light Body Fast (50ml* 2Cartridges)2023-06-16
08800024206288Delikit Implant Heavy BodyDelikit Implant Heavy Body (50ml*10Cartridges)2023-05-30
08800024205793Delikit 7.0 Light Body FastDelikit 7.0 Light Body Fast (9.7ml * 10cartrideges2023-05-25
08800024205885Delikit 7.0 Extra Light Body FastDelikit 7.0 Extra Light Body Fast (9.8ml*10cartrid2023-05-25
08800024206165Denture Soft RelinerDenture Soft Reliner (50ml Cartridge)2023-05-25
08800024206226Delikit Putty Eco Regular Set Delikit Putty Eco Regular Set (250ml+250ml)2023-05-25
08800024206240Delikit 3.0 Extra Light BodyDelikit 3.0 Extra Light Body (4.5ml * 10 Cartridge2023-05-25
08800024206264Delikit Extra Light Body FastDelikit Extra Light Body Fast (50ml* 4Cartridges)2023-05-25
08800024206189SUPPRA VPS Heavy Body Fast SetSUPPRA VPS Heavy Body Fast Set (50ml* 4Cartridges)2023-05-22
08800024206196SUPPRA VPS Light Body Fast SetSUPPRA VPS Light Body Fast Set (50ml* 4Cartridges)2023-05-22
08800024206202SUPPRA Putty Fast SetSUPPRA Putty Fast Set (250ml+250ml)2023-05-22
08800024206219SUPPRA Bite RegistrationSUPPRA Bite Registration (50ml * 2 Cartridges)2023-05-22
08800024204017Delikit 3.0 Extra Light Body FastDelikit 3.0 Extra Light Body Fast(4.5ml*25Cartridg2022-12-07
08800024204413Delikit 7.0 Light BodyDelikit 7.0 Light Body(9.7ml * 20cartrideges)2022-12-07
08800024204222Delikit Biggg Heavy BodyDelikit Biggg Heavy Body(75ml* 2 Cartridges)2022-09-14
08800024203270Delikit Light Body FSDelikit Light Body fast (50ml * 2 Cartridges)2022-05-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850078989369SmileSet Impression Kit - RetainerOrtho Dental Lab LLCELW2026-03-20
00850078989376SmileSet Impression Kit - Night GuardOrtho Dental Lab LLCELW2026-03-20
00860014754630Owl Impression KitOWL DENTAL LAB INCELW2026-03-05
E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
08719327516010Cavex CleverCast - Normal SetCavex Holland B.V.ELW2026-03-05
E241AA6050Cavex Cream FastCavex Holland B.V.ELW2026-03-04
E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
07630243601691AdhesiveDent4You AGELW2026-02-10
00850079280427CAvexHexa DentalELW2026-01-22
00850079280014One PlusHexa DentalELW2026-01-21
00085007928014One PlusHexa DentalELW2026-01-21
00850057092240HexaHexa DentalELW2026-01-21
00850057092929One PlusHexa DentalELW2026-01-21
00850057092936One PlusHexa DentalELW2026-01-21
00850057092943One PlusHexa DentalELW2026-01-21
00850057092950One PlusHexa DentalELW2026-01-21
00850057092967One PlusHexa DentalELW2026-01-21
00850057092974One PlusHexa DentalELW2026-01-21
00850057092981One PlusHexa DentalELW2026-01-21
00850079280007One PlusHexa DentalELW2026-01-21
00850079280021One PlusHexa DentalELW2026-01-21
00850079280304CavexHexa DentalELW2026-01-21
00850079280311cAVEXHexa DentalELW2026-01-21
00850079280328CavexHexa DentalELW2026-01-21
00850079280335CavexHexa DentalELW2026-01-21
00850079280342CavexHexa DentalELW2026-01-21
00850079280359CavexHexa DentalELW2026-01-21
00850057092714Hexa DentalHexa DentalELW2026-01-19
00850057092721Hexa dentalHexa DentalELW2026-01-19