FDA.reportPublic FDA data

OdneClean Tip

Primary DI
07649988156663
Brand
OdneClean Tip
Company
Odne AG
Model
E-0005
Device description
Root canal irrigation tip for use with OdneClean. Size 190x21. Box of 10 individually packed tips. Non-sterile
Published
2025-09-03
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
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233844000OdneCleanOdne AG2024-08-08ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649988156663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649988156663076499881566637649988156663

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480237899
Device count
1
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
07649988629341OdneFill Tips 25mmE-80202025-09-03
07649988072420OdneCure TipE-0008A-00052024-02-02
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

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