FDA.reportPublic FDA data

ResiCem EX

Primary DI
04548162300836
Brand
ResiCem EX
Company
SHOFU DENTAL CORPORATION
Model
C0100
Catalog number
C0100
Device description
ResiCem EX Automix 5mL (9.2g) Clear 1pc
Published
2026-07-04
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
false

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
K251470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251470000ResiCem EXShofu Dental Corporation2025-07-11EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
84548162300832Direct MarkingGS10
14548162300833PackageGS110In Commercial Distribution
04548162300836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8454816230083284548162300832
1454816230083314548162300833
04548162300836045481623008364548162300836

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
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(760) 736-3277customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
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
true
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
04548162300843ResiCem EXC0101C01012026-07-04
04548162300850ResiCem EXC0102C01022026-07-04
04548162300867ResiCem EXC0103C01032026-07-04
04548162344113ResiCem EXC0104C01042026-07-04
04548162350558GlossMaster ZRN0012N00122026-07-04
04548162350565GlossMaster ZRN0013N00132026-07-04
04548162350572GlossMaster ZRN0014N00142026-07-04
04548162350589GlossMaster ZRN0015N00152026-07-04
04548162350596GlossMaster ZRN0016N00162026-07-04
04548162350602GlossMaster ZRN0017N00172026-07-04
04548162350619GlossMaster ZRN0018N00182026-07-04
04548162350626GlossMaster ZRN0019N00192026-07-04
04548162350633GlossMaster ZRN0020N00202026-07-04
04548162350640GlossMaster ZRN0021N00212026-07-04
04548162350657GlossMaster ZRN0022N00222026-07-04
04548162350664GlossMaster ZRN0023N00232026-07-04
E235Y00030SHOFU RESIN GLAZEY0003Y00032026-06-08
E235Y00040SHOFU RESIN GLAZEY0004Y00042021-02-03
E235DPC0DentaprintDPCDPC2026-04-29
E235DPM0DentaprintDPMDPM2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
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
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29
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10386040008754GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008761GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008778GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008785GC Fuji II LC®Gc America Inc.EMA2022-07-13