FDA.reportPublic FDA data

UltraSil Putty 1000

Primary DI
D95600USP1000
Brand
UltraSil Putty 1000
Company
D.S.I DENTAL SOLUTIONS LTD
Model
US-P1000
Published
2024-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222741000DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)Hdi, Inc.2022-11-07ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D95600USP1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Composite dental impression materialA thermoplastic material designed 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. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532290720
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95600ZOERF0Zoer ReinforcedZOER-RF2023-02-15
D9560ZOERQS0Zoer QuickZOER-QS2023-02-15
D9560SILFLO5Sil-FlowSILFLO52025-06-26
D9560000ULA0UniLite Universal Composite 4g Bleach A0UL-A02024-06-26
D9560000ULA1UniLite Universal Composite 4g A1UL-A12024-06-26
D9560000ULA2UniLite Universal Composite 4g A2UL-A22024-06-26
D9560000ULA3UniLite Universal Composite 4g A3UL-A32024-06-26
D9560000ULB1UniLite Universal Composite 4g B1UL-B12024-06-26
D9560000ULB2UniLite Universal Composite 4g B2UL-B22024-06-26
D9560000ULB3UniLite Universal Composite 4g B3UL-B32024-06-26
D956000ULA35UniLite Universal Composite 4g A3.5UL-A352024-06-26
D956000ULUD0UniLite Universal Composite 4g Opaque UniversalUL-UD2024-06-26
D956000USP800UltraSil Putty 800US-P8002024-06-26
D95600ULFNA0UniLite Flow 2 x 2g Bleach A0ULFN-A02024-06-26
D95600ULFNA1UniLite Flow 2 x 2g Composite A1ULFN-A12024-06-26
D95600ULFNA2UniLite Flow 2 x 2g Composite A2ULFN-A22024-06-26
D95600ULFNA3UniLite Flow 2 x 2g Composite A3ULFN-A32024-06-26
D95600ULFNB1UniLite Flow 2 x 2g Composite B1ULFN-B12024-06-26
D95600ULFNB2UniLite Flow 2 x 2g Composite B2ULFN-B22024-06-26
D95600ULFNB3UniLite Flow 2 x 2g Composite B3ULFN-B32024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28