FDA.reportPublic FDA data

OverCEM SA Translucent Starter Kit

Primary DI
08059388440092
Brand
OverCEM SA Translucent Starter Kit
Company
OVERFIBERS SRL
Model
OverCEM SA Translucent Starter Kit
Catalog number
KOCTR
Published
2025-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K242366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242366000OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.2025-01-10EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059388440092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059388440092080593884400928059388440092

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, Specify00Keep away from heat, moisture and direct sunlight
Storage Environment Temperature2 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431704826
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059388443307NeobondNeobondDPNEO12025-08-26
08059388441167Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388441174Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388441181Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388441198Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388441204Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388441211Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388441228Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388441235Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388441242Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388441259Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388441365Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388441372Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388441389Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388441396Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388441402Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388441518Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388441525Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388441556Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388441563Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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