FDA.reportPublic FDA data

Metacem A3

Primary DI
08806387894063
Brand
Metacem A3
Company
Meta Biomed Co., Ltd.
Model
9406
Device description
Metacem is a high strength, permanent visible light cured (VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bond systems, to adhesively bond and lute indirect restorations to tooth structure.
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171449000MetacemMeta Biomed Co., Ltd.2018-05-15EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387894063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387894063088063878940638806387894063

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.

Regulatory Flags#

DUNS number
688322841
Device count
1
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
08806387894049Metacem Set94042018-08-30
08806387894803Metapex Plus 0.894802021-04-16
08806387809388MG 04-15/40 LM09382025-08-26
08806387809395MG 06-15/40 LM09392025-08-26
08806387892090Meta Etchant92092016-09-19
08806387814603MX 02-1514602025-08-26
08806387814610MX 02-2014612025-08-26
08806387814627MX 02-2514622025-08-26
08806387814634MX 02-3014632025-08-26
08806387814641MX 02-3514642025-08-26
08806387814658MX 02-4014652025-08-26
08806387814665MX 04-1514662025-08-26
08806387814672MX 04-2014672025-08-26
08806387814689MX 04-2514682025-08-26
08806387814696MX 04-3014692025-08-26
08806387814702MX 04-3514702025-08-26
08806387814719MX 04-4014712025-08-26
08806387814726MX 06-1514722025-08-26
08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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10386040008778GC Fuji II LC®Gc America Inc.EMA2022-07-13
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10386040008792GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008808GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008815GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008822GC Fuji II LC®Gc America Inc.EMA2022-07-13