FDA.report

OverCEM Cer-Abutment Starter Kit

Primary DI
08059388440078
Brand
OverCEM Cer-Abutment Starter Kit
Company
OVERFIBERS SRL
Model
OverCEM Cer-Abutment Starter Kit
Catalog number
KOCCE
Published
2025-02-24
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
true

Related Records

Product Codes

CodeName
EMACement, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions

SubmissionSupplement
K242366000

Premarket Details

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

IdentifierTypeAgencyPackage quantityStatus
08059388440078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08059388440078080593884400788059388440078

GMDN Terms

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

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

Regulatory Flags

DUNS number
431704826
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
false
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 DIBrandModelCatalogPublished
08059388443307NeobondNeobondDPNEO12025-08-26
08059388442911Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388442928Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388442935Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388442942Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388442959Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388443215Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388443222Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388443239Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388443246Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388443253Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388442966Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388442973Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388442980Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388442997Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388443000Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388443017Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388443024Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388442881Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388442898Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

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