FDA.reportPublic FDA data

Sil-Flow

Primary DI
D9560SILFLO5
Brand
Sil-Flow
Company
D.S.I DENTAL SOLUTIONS LTD
Model
SILFLO5
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250778000Sil-FlowDsi Dental Solutions, Ltd.2025-05-23EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9560SILFLO5PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.

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
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
D95600ULFNS0UniLite Flow KitULFN-S2024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062160332Build-It FRKerr CorporationEBF2026-10-27
00195062160349Build-It FRKerr CorporationEBF2026-10-27
00195062160356Build-It FRKerr CorporationEBF2026-10-27
00195062160363Build-It FRKerr CorporationEBF2026-10-27
00195062160370Build-It FRKerr CorporationEBF2026-10-27
00195062160387Build-It FRKerr CorporationEBF2026-10-27
00195062160394Build-It FRKerr CorporationEBF2026-10-27
00195062160400Build-It FRKerr CorporationEBF2026-10-27
00195062160417Build-It FRKerr CorporationEBF2026-10-27
00195062160424Build-It FRKerr CorporationEBF2026-10-27
00195062160431Build-It FRKerr CorporationEBF2026-10-27
00195062160448Build-It FRKerr CorporationEBF2026-10-27
00195062160455Build-It FRKerr CorporationEBF2026-10-27
00195062160462Build-It FRKerr CorporationEBF2026-10-27
00195062160479Build-It FRKerr CorporationEBF2026-10-27
00195062160486Build-It FRKerr CorporationEBF2026-10-27
00195062160493Build-It FRKerr CorporationEBF2026-10-27
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746674TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746681TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25