Any-Com Bulk

Primary DI
08809518345007
Brand
Any-Com Bulk
Company
MEDICLUS CO.,LTD
Model
307-12 Any-Com Bulk A2
Catalog number
EC2501001
Device description
Any-Com Bulk is a light-cured, radiopaque, flowable restorative material, A2, 2g, 1syringe
Published
2026-05-21
Public version status
New
Distribution status
Not 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
K242713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242713000Any-Com BulkMediclus Co., Ltd.2025-02-07EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809518345007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809518345007088095183450078809518345007

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
Weight2Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
688304449
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809518344994Any-Com Bulk307-11 Any-Com Bulk A1EC25010012026-05-21
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

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