OdneCure Tip

Primary DI
07649988072406
Brand
OdneCure Tip
Company
Odne AG
Model
E-0008
Catalog number
E-0008
Device description
Optical Fiber Curing Tip for use with OdneCure device
Published
2024-02-02
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

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480237899
Device count
10
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
true
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 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
07649988072420OdneCure TipE-0008A-00052024-02-02
07649988156632OdneCleanE-0003E-00032024-11-28
07649988156618OdneFillE-0002E-00022024-01-31
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
07649988072420OdneCure 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