FDA.reportPublic FDA data

Irriflex

Primary DI
07640159160120
Brand
Irriflex
Company
Produits dentaires S.A.
Model
21401
Catalog number
21401
Device description
Irriflex is a flexible cannula with radial opening for liquid ejection along the canal walls.Box of 40 cannulas.
Published
2019-09-10
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
07640159160120PrimaryGS10
07640159160199Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159160120076401591601207640159160120
07640159160199076401591601997640159160199

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct light

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41219212631info@pdsa.ch

Regulatory Flags#

DUNS number
480420090
Device count
40
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640159162711ROSEN ROOT-CANAL CEMENT102452022-06-15
07640159162728Eugenol - 15ml114202022-06-15
07640159162735Eugenol - 30 ml114212022-06-15
07640159162742Eugenol - 100 ml114222022-06-15
07640159162759ZINC OXIDE - 500g114302022-06-15
07640159162766ZINC OXIDE - 100g114312022-06-15
07640159162773ZINC OXIDE - 250g114322022-06-15
07640159162780ZINC OXIDE - 1'000g114332022-06-15
07640159162704EssenSeal10246EssenSeal2022-06-13
07640159163350Drill-A-Post - N°1225112023-05-24
07640159163367Drill-A-Post - N°2225122023-05-24
07640159163374Drill-A-Post - N°3225132023-05-24
07640159163381Drill-A-Post - N°4225142023-05-24
07640159163398Drill-A-Post - N°1 - Rack of 6 pieces225012023-05-24
07640159163404Drill-A-Post - N°2 - Rack of 6 pieces225022023-05-24
07640159163411Drill-A-Post - N°3 - Rack of 6 pieces225032023-05-24
07640159163428Drill-A-Post - N°4 - Rack of 6 pieces225042023-05-24
07640159160076HOOKED NEEDLE N. 1 RED202642022-06-21
07640159160083HOOKED NEEDLE N. 2 BLUE202652022-06-21
07640159160359CLASSIC NEEDLE N. 0 YELLOW202202022-06-21

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Primary DI, Brand, Company table
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G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
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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
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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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