FDA.reportPublic FDA data

Acrylic Block

Primary DI
14560227799024
Brand
Acrylic Block
Company
SUN MEDICAL CO.,LTD.
Model
MCL-013-A
Catalog number
TS05US
Device description
Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Dark Pink.
Published
2016-11-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24560227799021PackageGS14Not in Commercial Distribution
14560227799024PrimaryGS10
04560227799027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2456022779902124560227799021
1456022779902414560227799024
04560227799027045602277990274560227799027

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth35Millimeter
Length109Millimeter
Width109Millimeter

Storage And Handling#

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

Regulatory Flags#

DUNS number
690922612
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560227803397iCEM Universal PlusK223KA661012262026-02-09
04560227803403iCEM Universal PlusK224KA661012222026-02-09
04560227803410iCEM Universal PlusK226KA661012212026-02-09
04560227803427iCEM Universal PlusK221KA661012252026-02-09
04560227803434iCEM Universal PlusT224KA661012182026-02-09
04560227803441iCEM Universal PlusT223KA661012192026-02-09
04560227803458iCEM Universal PlusT225KA661012202026-02-09
04560227803465iCEM Universal PlusT226KA661012172026-02-09
04560227803472iCEM Universal PlusT221KA661012242026-02-09
04560227803489iCEM Universal PlusT227KA661012162026-02-09
04560227803496iCEM Universal PlusT228KA661012232026-02-09
04560227803557iCEM Universal PlusT227KA661012162026-02-09
04560227803564iCEM Universal PlusT228KA661012232026-02-09
14560227799000Acrylic BlockMCL-010-ATS01US 2016-11-07
14560227799017Acrylic BlockMCL-011-ATS03US2016-11-07
14560227799031Acrylic BlockMCL-010-BTS11US2016-11-07
14560227799048Acrylic BlockMCL-011-BTS13US2016-11-07
14560227799055Acrylic BlockMCL-013-BTS15US2016-11-07
14560227799062Acrylic BlockMCL-010-CTS21US2016-11-07
14560227799079Acrylic BlockMCL-011-CTS23US2016-11-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970402677596Denture Base PolymersSHANDONG HUGE DENTAL MATERIAL CORPORATIONEBI2026-10-25
00842326128132DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128149DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128156DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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