FDA.reportPublic FDA data

EsCom250

Primary DI
08809262953275
Brand
EsCom250
Company
Spident Co., Ltd.
Model
EsCom250 C2
Catalog number
#3203C2
Device description
EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809262953275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262953275088092629532758809262953275

GMDN Terms#

Term, Definition table
TermDefinition
Network serverA device designed to provide electronic data services within a computerized network (e.g., file services like collecting and storing data). It may be a part of a patient monitoring, nurse call, or home alert system.

Regulatory Flags#

DUNS number
689370711
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
08809262953602EsCemEsCem A22026-04-29
08809262953619EsCemEsCem A32026-04-29
08809262953626EsCemEsCem TW2026-04-29
08809262959000Temro.FlowTemp it Flow+ yellow 4ea2026-04-28
08809262959017Temro.FlowTemp it Flow+ Blu 4ea2026-04-28
08809262953206EsCom250EsCom250 A1#3203A12026-04-21
08809262953213EsCom250EsCom250 A2#3203A22026-04-21
08809262953220EsCom250EsCom250 A3#3203A32026-04-21
08809262953237EsCom250EsCom250 A3.5#3203A352026-04-21
08809262953244EsCom250EsCom250 A4#3203A42026-04-21
08809262953251EsCom250EsCom250 B1#3203B12026-04-21
08809262953268EsCom250EsCom250 B2#3203B22026-04-21
08809262953282EsCom250EsCom250 D2#3203D22026-04-21
08809262953299EsCom250EsCom250 G1#3203G12026-04-21
08809262953305EsCom250EsCom250 AO2#3203AO22026-04-21
08809262953312EsCom250EsCom250 AO3#3203AO32026-04-21
08809262953329EsCom250EsCom250 TW#3203TW2026-04-21
08809262953336EsCom250EsCom250 Capsule A1 20ea#3203A1PCA2026-04-21
08809262953343EsCom250EsCom250 Capsule A2 20ea#3203A2PCA2026-04-21
08809262953350EsCom250EsCom250 Capsule A3 20ea#3203A3PCA2026-04-21

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