FDA.reportPublic FDA data

ZIRCONOMER P

Primary DI
04548162345837
Brand
ZIRCONOMER P
Company
SHOFU DENTAL CORPORATION
Model
C0039
Catalog number
C0039
Device description
ZIRCONOMER P CAPSULE Universal Shade 3pcs (Sample)
Published
2026-04-10
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
K252165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252165000ZIRCONOMER PShofu Dental Corporation2025-10-28EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548162345837PrimaryGS10
84548162345833Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548162345837045481623458374548162345837
8454816234583384548162345833

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
054618202
Device count
3
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
E235DZ9812A10DENTADISC ZRDZ9812A1DZ9812A12026-08-23
E235DZ9812A20DENTADISC ZRDZ9812A2DZ9812A22026-08-23
E235DZ9812A30DENTADISC ZRDZ9812A3DZ9812A32026-08-23
E235DZ9812A350DENTADISC ZRDZ9812A35DZ9812A352026-08-23
E235DZ9812B10DENTADISC ZRDZ9812B1DZ9812B12026-08-23
E235DZ9812B20DENTADISC ZRDZ9812B2DZ9812B22026-08-23
E235DZ9812C10DENTADISC ZRDZ9812C1DZ9812C12026-08-23
E235DZ9812C20DENTADISC ZRDZ9812C2DZ9812C22026-08-23
E235DZ9812C30DENTADISC ZRDZ9812C3DZ9812C32026-08-23
E235DZ9812D20DENTADISC ZRDZ9812D2DZ9812D22026-08-23
E235DZ9812D30DENTADISC ZRDZ9812D3DZ9812D32026-08-23
E235DZ9814A10DENTADISC ZRDZ9814A1DZ9814A12026-08-23
E235DZ9814A20DENTADISC ZRDZ9814A2DZ9814A22026-08-23
E235DZ9814A30DENTADISC ZRDZ9814A3DZ9814A32026-08-23
E235DZ9814A350DENTADISC ZRDZ9814A35DZ9814A352026-08-23
E235DZ9814B10DENTADISC ZRDZ9814B1DZ9814B12026-08-23
E235DZ9814B20DENTADISC ZRDZ9814B2DZ9814B22026-08-23
E235DZ9814BL10DENTADISC ZRDZ9814BL1DZ9814BL12026-08-23
E235DZ9814BL20DENTADISC ZRDZ9814BL2DZ9814BL22026-08-23
E235DZ9814BL30DENTADISC ZRDZ9814BL3DZ9814BL32026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
08809911118536NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
08809911118543NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14