OdneCure Tip

Primary DI
07649988072420
Brand
OdneCure Tip
Company
Odne AG
Model
E-0008
Catalog number
A-0005
Device description
Optical Fiber Curing Tip for use with OdneCure device
Published
2024-02-02
Public version status
Update
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
QNFLaser Activator For Polymerization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNFLaser Activator For PolymerizationDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232076000FibercureLumendo AG2023-11-02QNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649988072406PackageGS170In Commercial Distribution
07649988072420PrimaryGS10
07649988156601Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649988072406076499880724067649988072406
07649988072420076499880724207649988072420
07649988156601076499881566017649988156601

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Regulatory Flags#

DUNS number
480237899
Device count
10
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
07649994994037OdneClean Tip 220x17E-00092025-12-12
07649994994044OdneClean Tip 220x21E-00102025-12-12
07649988156663OdneClean TipE-00052025-09-03
07649988629341OdneFill Tips 25mmE-80202025-09-03
07649988156632OdneCleanE-0003E-00032024-11-28
07649988156618OdneFillE-0002E-00022024-01-31
07649988072406OdneCure TipE-0008E-00082024-02-02
07649988072451OdneFill TipE-8000E-80002024-02-01
07649988072475OdneFill TipE-8000E-80002024-02-01
07649988156694OdneCureE-0001E-00012024-02-01
07649988156649OdneFillE-0002E-00022024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320006761Monet + Curing LaserCAO GROUP, INC.QNF2026-02-10
07649988072406OdneCure TipOdne AGQNF2024-02-02
07649988156694OdneCureOdne AGQNF2024-02-01
00872320005610Monet Curing LaserCAO GROUP, INC.QNF2020-12-14
00872320005627Monet Curing Laser Battery PackCAO GROUP, INC.QNF2020-12-14
00872320005634Monet Curing Laser Large GlassesCAO GROUP, INC.QNF2020-12-14
00872320005641Monet Curing Laser Small GlassesCAO GROUP, INC.QNF2020-12-14
00872320005665Monet Curing Laser Charging StandCAO GROUP, INC.QNF2020-12-14
00872320005948Monet Curing Laser Barrier SleeveCAO GROUP, INC.QNF2020-12-14