FDA.reportPublic FDA data

Precisil Bite Registration Trimming

Primary DI
08800024201443
Brand
Precisil Bite Registration Trimming
Company
Sherpakorea
Model
Precisil Bite Registration Trimming (50ml * 2Cartr
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024201443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024201443088000242014438800024201443

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+827078429961happidenco@naver.com

Regulatory Flags#

DUNS number
557822311
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
08800024205816Delikit 7.0 Light Body FastDelikit 7.0 Light Body Fast(9.7ml * 20cartrideges)2023-01-16
08800024205908Delikit 7.0 Extra Light Body FastDelikit 7.0 Extra Light Body Fast(9.7ml * 20cartri2023-01-16
08800024204420Delikit 7.0 Light Body RegularDelikit 7.0 Light Body Regular(9.7ml * 20cartrideg2023-01-12
08800024204451Delikit 3.0 Light BodyDelikit 3.0 Light Body(4.5ml* 10 Cartridges)2023-01-12

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18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
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18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
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18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
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