FDA.reportPublic FDA data

TrusFIL-Flow Flowable Composite Restorative

Primary DI
06970006746605
Brand
TrusFIL-Flow Flowable Composite Restorative
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
/
Catalog number
DR/2g
Published
2026-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K221510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221510000TrusFIL-Flow Flowable Composite RestorativeRizhao Huge Biomaterials Company, Ltd.2022-10-12EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970006746605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970006746605069700067466056970006746605

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
544452689
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970006745660Light Cure Dental Adhesive/6ml2026-10-25
06970006745677Universal Composite Restorative/A2/4g/TrusFIL X-Blend2026-10-25
06970006746568Phosphoric Acid Etching GelE371ml*12026-10-25
06970006746575TrusFIL-Flow Flowable Composite Restorative/DO/2g2026-10-25
06970006746582TrusFIL-Flow Flowable Composite Restorative/PR/2g2026-10-25
06970006746599TrusFIL-Flow Flowable Composite Restorative/Br/2g2026-10-25
06970006746612TrusFIL-Flow Flowable Composite Restorative/LR/2g2026-10-25
06970006746629TrusFIL-Flow Flowable Composite Restorative/P1/2g2026-10-25
06970006746636TrusFIL-Flow Flowable Composite Restorative/P2/2g2026-10-25
06970006746643TrusFIL-Flow Flowable Composite Restorative/P3/2g2026-10-25
06970006746650TrusFIL-Flow Flowable Composite Restorative/YP/2g2026-10-25
06970006746667TrusFIL-Flow Flowable Composite Restorative/DP/2g2026-10-25
06970006746674TrusFIL-Flow Flowable Composite Restorative/LT/2g2026-10-25
06970006746681TrusFIL-Flow Flowable Composite Restorative/WO/2g2026-10-25
06970006746698TrusFIL-Flow Flowable Composite Restorative/WT/2g2026-10-25
06970006746704Universal Composite Restorative/DO/4g2026-10-25
06970006746711Universal Composite Restorative/PR/4g2026-10-25
06970006746728Universal Composite Restorative/DR/4g2026-10-25
06970006746735Universal Composite Restorative/LR/4g2026-10-25
06970006746742Universal Composite Restorative/P1/4g2026-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
06970006746698TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746704Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746711Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746728Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746735Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746742Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746759Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746766Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746773Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746780Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746797Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746803Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746810Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746827Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489016TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489023TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489047TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06972220489054TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25