FDA.reportPublic FDA data

iCEM Universal Plus

Primary DI
04560227803557
Brand
iCEM Universal Plus
Company
SUN MEDICAL CO.,LTD.
Model
T227KA
Catalog number
66101216
Device description
iCEM Universal Plus Mixing 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
OTC
false
Sterile
false
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
04560227803489PrimaryGS10
04560227803557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560227803489045602278034894560227803489
04560227803557045602278035574560227803557

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690922612
Device count
20
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
false
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
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195062159794Breeze RMGIKerr CorporationEMA2026-10-27
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29