FDA.reportPublic FDA data

Neobond

Primary DI
08059388443307
Brand
Neobond
Company
OVERFIBERS SRL
Model
Neobond
Catalog number
DPNEO1
Published
2025-08-26
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
08059388443307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059388443307080593884433078059388443307

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
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
08059388441570Polygon Over Post # 3Polygon Over Post # 3PYOP032025-03-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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