FDA.reportPublic FDA data

CanalPro™ Color Syringes

Primary DI
E165600193221
Brand
CanalPro™ Color Syringes
Company
Coltène/Whaledent GmbH + Co. KG
Model
60019322
Catalog number
60019322
Device description
CanalPro™ Color Syringes (5 ml) blue
Published
2023-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E165600193221PrimaryHIBCC0
E165600193220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+ 4973458050info.de@coltene.com

Regulatory Flags#

DUNS number
315494443
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E1654610480ROEKO Aspirator tips4610484610482016-08-23
E1654620120ROEKO Surgitip-micro4620124620122016-08-23
E1654620130ROEKO Surgitip-micro4620134620132016-08-23
E1654620250ROEKO Surgitip4620254620252016-08-23
E1654620260ROEKO Surgitip4620264620262016-08-23
E1654620480ROEKO Surgitip4620484620482016-08-23
E1654620490ROEKO Surgitip4620494620492016-08-23
E1654630000ROEKO Double adapter4630004630002016-08-23
E1654630110ROEKO Adapter4630114630112016-08-23
E1654630250ROEKO Adapter4630254630252016-08-23
E165600182800ROEKO Surgitip-endo60018280600182802016-08-23
E165600191450ROEKO SurgitipSAMPLE EN600191452016-08-23
14260614073576HyFlex EDM60041081600410812025-10-22
14260614073583HyFlex EDM60041082600410822025-10-22
14260614073590HyFlex EDM60041083600410832025-10-22
14260614073606HyFlex EDM60041084600410842025-10-22
14260614073613HyFlex EDM60041085600410852025-10-22
14260614073620HyFlex EDM60041086600410862025-10-22
14260614073637HyFlex EDM60041087600410872025-10-22
14260614073644HyFlex EDM60041088600410882025-10-22

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Primary DI, Brand, Company table
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00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02
00850440008667IrriGator Flex TipEngineered Endodontics, LLCEIC2026-01-02
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00810118106453NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106521Avalon Biomed Clear Flex Tips - 4 PackNUSMILE, LTD.EIC2025-07-15
00810118106538Avalon Biomed Clear Flex Tips - 20 PackNUSMILE, LTD.EIC2025-07-15
00810118106545Avalon Biomed Clear Flex Tips - 40 PackNUSMILE, LTD.EIC2025-07-15
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