FDA.reportPublic FDA data

iCEM Universal Plus

Primary DI
04560227803496
Brand
iCEM Universal Plus
Company
SUN MEDICAL CO.,LTD.
Model
T228KA
Catalog number
66101223
Device description
iCEM Universal Plus Endo Tips
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254063000iCEM Universal PlusKulzer, LLC2025-12-19EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560227803496PrimaryGS10
04560227803564Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560227803496045602278034964560227803496
04560227803564045602278035644560227803564

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place

Contacts#

Phone, Email table
PhoneEmail
+1(800)431-1785customerservice.na@kulzer-dental.com

Regulatory Flags#

DUNS number
690922612
Device count
20
Lot or batch
true
Manufacturing 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
04560227803557iCEM Universal PlusT227KA661012162026-02-09
04560227803564iCEM Universal PlusT228KA661012232026-02-09
14560227799000Acrylic BlockMCL-010-ATS01US 2016-11-07
14560227799017Acrylic BlockMCL-011-ATS03US2016-11-07
14560227799024Acrylic BlockMCL-013-ATS05US 2016-11-07
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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08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
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