FDA.reportPublic FDA data

Once-Fil Flow

Primary DI
08809518340651
Brand
Once-Fil Flow
Company
MEDICLUS CO.,LTD
Model
101-1
Catalog number
EC2501001
Device description
Once-Fil Flow is a light-curing temporary filling material. Blue shade.
Published
2026-05-28
Public version status
New
Distribution status
Not 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
K251283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251283000Once-Fil FlowMediclus Co., Ltd.2025-06-06EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809518340651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809518340651088095183406518809518340651

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
688304449
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809518346721Disposable Tip650032252026-06-05
08809518341511Any-Paste505-1EC25010012026-06-01
08809518342105Hi-Bond Universal303-2EC25010012026-06-01
08809518340668Once-Fil Flow101-2EC25010012026-05-28
08809518344994Any-Com Bulk307-11 Any-Com Bulk A1EC25010012026-05-21
08809518345007Any-Com Bulk307-12 Any-Com Bulk A2EC25010012026-05-21
08809518345014Any-Com Bulk307-13 Any-Com Bulk A3EC25010012026-05-21
08809518345021Any-Com Bulk307-14 Any-Com Bulk BlueEC25010012026-05-21
08809518345038Any-Com Bulk307-15 Any-Com Bulk TLEC25010012026-05-21
08809518345106One-Fil Putty Injectable509-1 One-Fil Putty InjectableEC25010012026-05-21
08809518341252One-Fil508-1 One-FilEC25010012026-05-11
08809518343706One-Fil Putty509-2 One-Fil PuttyEC25010012026-05-11
08809518346608CanalPro CalciSeal60043033600430332026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208476804Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477719Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477726Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477733Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477740Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477757Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477764Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477771Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477788Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07