FDA.report

Vista 12cc w 30ga Irrigating Tip

Primary DI
10818207023596
Brand
Vista 12cc w 30ga Irrigating Tip
Company
Vista Dental
Model
316119
Published
2022-09-01
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

Related Records

Contact Domains

Product Codes

CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818207023596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081820702359610818207023596

GMDN Terms

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

Contacts

PhoneEmail
2626369755info@vista-dental.com

Regulatory Flags

DUNS number
036623932
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30
10818207024982Traxodent Gel AlCl - Value Pack90071022025-06-30
10818207024999Traxodent Gel AlCl - Refill Kit90071032025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe Kit90071062025-06-30
10818207025019Traxodent Gel FS - Value Pack90071072025-06-30
10818207025026Traxodent Gel FS - Refill Kit90071082025-06-30
10818207025033Traxodent Gel Brush Tips90071052025-06-30
10818207025040UniClean90071002025-06-30
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207024913RE-GEN Bioactive EndoPutty Kit5047562024-11-14
10818207024876REGEN Bioactive EndoSealer (SS MST Kit)5047542024-02-02
10818207024838Vista MST Visco Tip SS 17mm 50/cup3124112023-10-02
10818207024845Vista MST Visco Tip SS 22mm 50/cup3124122023-10-02
10818207024852Vista MST Visco Tip SS 17mm 20/cup3124132023-10-02
10818207024869Vista MST Visco Tip SS 22mm 20/cup3124142023-10-02
10818207024333VacuSeal Syringe3713A2023-06-09
10818207024340SmearOFF System (PS System)3730A2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)803803-162023-06-09
10818207024364PS System - Anterior Kit60000022023-06-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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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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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