FDA.reportPublic FDA data

One-Temp Flow

Primary DI
08809518345670
Brand
One-Temp Flow
Company
MEDICLUS CO.,LTD
Model
104-2
Catalog number
EC2501001
Device description
One-Temp Flow is a light-curing temporary filling material. A2 Shade.
Published
2026-08-12
Public version status
Update
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
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
08809518340668PreviousGS10
08809518345670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809518340668088095183406688809518340668
08809518345670088095183456708809518345670

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
08809518346677CanalPro CalciSeal65003227650032272026-09-22
08809518345663One-Temp Flow104-1EC25010012026-08-12
08809518346721Disposable Tip650032252026-06-05
08809518341511Any-Paste505-1EC25010012026-06-01
08809518342105Hi-Bond Universal303-2EC25010012026-06-01
08809518340651Once-Fil Flow101-1EC25010012026-05-28
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
00195062153846NeoFilKerr CorporationEBF2026-11-04
00766054003045BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003052BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003069BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003076BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003083BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003090BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003106BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003113BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003120BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003137BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
EDMG2228071Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228081Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228091Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228121Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228131Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228141Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228151Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228161Ecosite Elements Highlight Refill IncisalDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228181Ecosite Elements Highlight Refill WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228191Ecosite Elements Highlight Refill BrownDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228201Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228211Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228221Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228231Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228251Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228261Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228271Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30